NDC 71589-007 Clobetasol Propionate

Clobetasol Propionate

NDC Product Code 71589-007

NDC 71589-007-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Clobetasol Propionate with NDC 71589-007 is a a human prescription drug product labeled by Aleor Dermaceuticals Limited. The generic name of Clobetasol Propionate is clobetasol propionate. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Aleor Dermaceuticals Limited

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clobetasol Propionate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CLOBETASOL PROPIONATE .05 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCO-BETAINE (UNII: 03DH2IZ3FY)
  • POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Aleor Dermaceuticals Limited
Labeler Code: 71589
FDA Application Number: ANDA213290 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Clobetasol Propionate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1.1 Indication

Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2) ].Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

1.2 Limitations Of Use

Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.

2 Dosage And Administration

Clobetasol propionate shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.Clobetasol propionate shampoo, 0.05%, should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying clobetasol propionate shampoo, 0.05%.Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after 4 weeks of treatment with clobetasol propionate shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.Clobetasol propionate shampoo, 0.05%, should not be used with occlusive dressings (shower cap or bathing cap) unless directed by a physician.

3 Dosage Forms And Strengths

Shampoo, 0.05%, w/w. Each gram of clobetasol propionate shampoo, 0.05%, contains 0.5 mg of clobetasol propionate, USP in a translucent, colorless to pale yellow viscous liquid.

4 Contraindications

None

5.1 Effects On The Endocrine System

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.The effect of clobetasol propionate shampoo, 0.05% on HPA axis suppression was evaluated in one trial in adolescents 12 to 17 years of age. In this trial, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05% applied once daily for 15 minutes to a dry scalp before lathering and rinsing.Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure.Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

5.2 Allergic Contact Dermatitis

If irritation develops, clobetasol propionate shampoo, 0.05%, should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed with patch testing.

5.3 Concomitant Skin Infections

In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of clobetasol propionate shampoo, 0.05%, should be discontinued until the infection has been adequately controlled.

5.4 Local Adverse Reactions With Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Clobetasol propionate is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.In clinical trials with clobetasol propionate shampoo, 0.05%, the following adverse reactions have been reported: headache, burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.Table 1 summarizes selected adverse reactions that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis. Table 1: Summary of Selected Adverse Reactions ≥ 1% by Body System Body System Clobetasol Propionate Shampoo, 0.05% N=558 Vehicle Shampoo N=127 Skin and Appendages 49 (8.8%) 28 (22.0%) Discomfort Skin 26 (4.7%) 16 (12.6%) Pruritus 3 (0.5%) 9 (7.1%) Body as a Whole 33 (5.9%) 12 (9.4%) Headache 10 (1.8%) 1 (0.8%)Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

6.2 Postmarketing Experience

  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of clobetasol propionate shampoo, 0.05%.  Endocrine disorders: Cushing's syndrome, Adrenal suppression  Eye: Eye pain, Vision blurred, Eye irritation  CNS: Dizziness  GI: Nausea  Skin: Erythema, Skin exfoliation, Rash, Skin irritation, Hair color changes, Allergic contact dermatitis, Pain of skin, Skin tightness  Other: Psoriasis (aggravation)

8.1 Pregnancy

Teratogenic effects: Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Therefore, clobetasol propionate shampoo, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse.Clobetasol propionate has greater teratogenic potential than steroids that are less potent.The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 mcg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal no-observed-effect-level (NOEL) for clobetasol propionate was less than 12.5 mcg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 mcg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 mcg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.

8.3 Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate shampoo, 0.05%, is administered to a nursing woman.

8.4 Pediatric Use

Use of clobetasol propionate shampoo, 0.05%, in patients under 18 years old is not recommended due to potential for HPA axis suppression [see Warnings and Precautions (5.1)].The effect of clobetasol propionate shampoo, 0.05%, on HPA axis suppression was evaluated in one trial in adolescents 12 to 17 years of age with moderate to severe scalp psoriasis with involvement of at least 25% of the scalp. In this trial, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05%, applied once daily for 15 minutes to a dry scalp before lathering and rinsing. Only 1 of the 5 subjects who had suppression was tested for recovery of HPA axis, and this subject recovered after 2 weeks.No studies have been performed in patients under the age of 12. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. Therefore, use is not recommended in patients under the age of 18.HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5 Geriatric Use

Clinical studies of clobetasol propionate shampoo, 0.05%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

10 Overdosage

Topically applied, clobetasol propionate shampoo, 0.05%, can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

11 Description

Clobetasol Propionate Shampoo, 0.05%, contains clobetasol propionate, USP a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate, USP is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate.It has the following structural formula:Clobetasol propionate, USP has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate, USP is a white to practically white crystalline, odorless powder insoluble in water.Each gram of clobetasol propionate shampoo, 0.05%, contains 0.5 mg of clobetasol propionate, USP in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.

12.1 Mechanism Of Action

Like other topical corticosteroids, clobetasol propionate shampoo, 0.05%, has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

12.2 Pharmacodynamics

Vasoconstrictor AssayClobetasol propionate shampoo, 0.05%, is in the super-high range of potency as demonstrated in vasoconstrictor studies in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.Hypothalamic-Pituitary-Adrenal (HPA) Axis SuppressionIn studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, use of clobetasol propionate shampoo, 0.05%, resulted in demonstrable HPA axis suppression in 5 out of 12 (42%) adolescent subjects [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion.Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 mcg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis).Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks.Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test.The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 mcg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 mcg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles. The female reproductive NOEL was 12.5 mcg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

14 Clinical Studies

The safety and efficacy of clobetasol propionate shampoo, 0.05%, have been evaluated in two clinical trials involving 290 subjects with moderate to severe scalp psoriasis. In both trials, subjects were treated with either clobetasol propionate shampoo or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in Table 2 below.1Success rate defined as the proportion of subjects with a-0 (clear) or 1 (minimal) on a 0 to 5 point physician's Global Severity Scale for scalp psoriasis. 2At four (4) weeks or last observation recorded for a subject during the treatment period (baseline if no post-baseline data were available). 3Subjects with 0 (clear) on a 0 to 3 point scalp psoriasis parameter scale. Table 2: Efficacy Results Clobetasol Propionate Shampoo, 0.05% N (%) Shampoo Vehicle n (%) Study A Study B Study A Study B Total Number of Subjects 95 99 47 49 Success Rate1 at Endpoint2 40 (42.1%) 28 (28.3%) 1 (2.1%) 5 (10.2%) Subjects with Scalp Psoriasis Parameter Clear (None) at Endpoint Erythema3 Scaling3 Plaque Thickening3 17 (17.9%) 21 (22.1%) 35 (36.8%) 12 (12.1%) 15 (15.2%) 34 (34.3%) 3 (6.4%) 0 (0%) 5 (10.6%) 1 (2.0%) 2 (4.1%) 5 (10.2%)Clinical studies of clobetasol propionate shampoo, 0.05%, did not include sufficient numbers of non-Caucasian subjects to determine whether they respond differently than Caucasian subjects with regards to efficacy and safety.

16 How Supplied/Storage And Handling

Clobetasol Propionate Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles.NDC 71589-007-04Storage: Keep tightly closed. Store at USP controlled room temperature 68˚ to 77˚F (20˚ to 25˚C), with excursions permitted between 59˚ and 86˚F (15˚ to 30˚C).

17 Patient Counseling Information

  • See FDA-approved patient labeling (Patient Information)Information for PatientsInform the patient using topical corticosteroids to adhere to following instructions:  This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.  Clobetasol propionate shampoo, 0.05%, is for external use only. It should not be used on the face, underarms or groin areas. Avoid contact with the eyes and lips.  This medication should not be used for any disorder other than that for which it was prescribed.  The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician.  Patients should report any signs of local or systemic adverse reactions to their physician.  As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.  Patients should wash their hands after applying the medication.  Patients should inform their physician(s) that they are using clobetasol propionate shampoo, 0.05%, if surgery is contemplated.  Do not use other corticosteroid-containing products while using clobetasol propionate shampoo, 0.05%.  Patients should not use more than 50 g (50 mL or 1.75 fl. oz.) per week of clobetasol propionate shampoo, 0.05%.Patient InformationClobetasol Propionate (kloe bay' ta sol proe' pee oh nate) Shampoo, 0.05% Important: For use on the scalp only. Do not get clobetasol propionate shampoo near or in your eyes, mouth or vagina.Read the Patient Information that comes with clobetasol propionate shampoo before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.What is clobetasol propionate shampoo?Clobetasol propionate shampoo is a prescription corticosteroid medicine used to treat adults with moderate to severe forms of scalp psoriasis. Clobetasol propionate shampoo is for use on the scalp only (topical).Clobetasol propionate shampoo should be used for the shortest amount of time needed to treat your scalp psoriasis.You should not use clobetasol propionate shampoo for longer than 4 weeks in a row.You should not use more than 50 mL (1.75 fluid ounces) of clobetasol propionate shampoo in one week.You should not use clobetasol propionate shampoo:  on your face, underarms (armpits) or groin areas. Avoid getting clobetasol propionate shampoo in your eyes or on your lips.Clobetasol propionate shampoo should not be used in children under 18 years of age.What should I tell my doctor before using clobetasol propionate shampoo?Before you use clobetasol propionate shampoo, tell your doctor if you:have a scalp infection. You may need medicine to treat the scalp infection before you use clobetasol propionate shampoo.have any open sores or cuts on your scalpplan to have surgeryhave acne vulgaris, rosacea, or a rash around your mouth (perioral dermatitis)have any other medical conditionsare pregnant or plan to become pregnant. It is not known if clobetasol propionate shampoo can harm your unborn baby.are breast-feeding or plan to breast-feed. It is not known if clobetasol propionate shampoo passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use clobetasol propionate shampoo.Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using clobetasol propionate shampoo. Ask your doctor or pharmacist if you are not sure.Know the medicines you take. Keep a list of them to show your doctor and pharmacist if you get a new medicine.How should I use clobetasol propionate shampoo?Use clobetasol propionate shampoo exactly as your doctor tells you to use it.Your doctor should tell you how much clobetasol propionate shampoo to use and where to apply it.Clobetasol propionate shampoo is for use on your scalp only (topical).Apply clobetasol propionate shampoo on affected areas of your scalp one time each day.Use only enough clobetasol propionate shampoo to cover the affected areas of your scalp.Do not use clobetasol propionate shampoo on your face, groin, or underarms. Avoid getting clobetasol propionate shampoo in your eyes or on your lips.Do not wet your hair before using clobetasol propionate shampoo.If clobetasol propionate shampoo gets on any part of your body other than your scalp, rinse the area well with water.You should not bandage or cover your head with a shower cap, bathing cap, or a towel, while clobetasol propionate shampoo is on your scalp, unless your doctor tells you to.Tell your doctor if your scalp condition is not getting better after 4 weeks of using clobetasol propionate shampoo. You should not use clobetasol propionate shampoo for more than 4 weeks unless your doctor tells you to.See the "Instructions for Use" at the end of the Patient Information for detailed information about the right way to use clobetasol propionate shampoo.What are the possible side effects of clobetasol propionate shampoo?Clobetasol propionate shampoo can pass through your skin. Too much clobetasol propionate shampoo passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.The most common side effects of clobetasol propionate shampoo include:  burning or stinging at the site of application  itching  swelling  inflamed hair follicle  acne  dry, itchy and reddened skin  hair loss  rash or hives  thinning of the skin  widening of small blood vessels in the skinIf you go to another doctor for illness, injury or surgery, tell that doctor that you are using clobetasol propionate shampoo.Tell your doctor if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of clobetasol propionate shampoo. For more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.You may also report side effects to Alembic Pharmaceuticals Inc. at 1-866-210-9797.How should I store clobetasol propionate shampoo?  Store clobetasol propionate shampoo at room temperature between 68˚ to 77˚F (20˚ to 25˚C).  Keep the clobetasol propionate shampoo bottle tightly closed.Keep clobetasol propionate shampoo and all medicines out of the reach of children.General information about clobetasol propionate shampooMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use clobetasol propionate shampoo for a condition for which it was not prescribed. Do not give clobetasol propionate shampoo to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about clobetasol propionate shampoo. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about clobetasol propionate shampoo that is written for health professionals.What are the ingredients in clobetasol propionate shampoo?Active ingredient: clobetasol propionateInactive ingredients (shampoo base): alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate and sodium laureth sulfate.Instructions for UseClobetasol propionate (kloe bay' ta sol proe' pee oh nate) Shampoo, 0.05% Important: For use on the scalp only. Do not get clobetasol propionate shampoo near or in your eyes, mouth or vagina.Read the Instructions for Use that comes with clobetasol propionate shampoo before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.How to apply clobetasol propionate shampoo to your scalp:Your hair should be dry when you apply clobetasol propionate shampoo to your scalp.Do not get clobetasol propionate shampoo on your face, in your eyes or on your lips. If clobetasol propionate shampoo does get on these areas, rinse well with water.Step 1: To apply clobetasol propionate shampoo to your scalp, part your hair at the area where it is to be applied.Step 2: Hold the bottle of clobetasol propionate shampoo over the affected area. Gently squeeze the bottle and apply a small amount of shampoo to the affected area.Step 3: Gently rub clobetasol propionate shampoo into the affected area so that only the affected area is covered with a thin, even layer of clobetasol propionate shampoo.Step 4: Repeat Steps 1 through 3 to apply clobetasol propionate shampoo to other affected areas on your scalp as instructed by your doctor.Step 5: Wash your hands after applying clobetasol propionate shampoo.Step 6: Leave clobetasol propionate shampoo on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel while clobetasol propionate shampoo is on your scalp, unless your doctor tells you to.Step 7: After 15 minutes have passed, wet your hair with water. Lather and rinse your hair and scalp completely. Rinse any other parts of your body that come into contact with clobetasol propionate shampoo, such as your hands, face, neck and shoulders.No other shampoo is needed, but you may wash your hair with a non-medicated shampoo after using clobetasol propionate shampoo.This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.Manufactured for:Aleor Dermaceuticals Ltd.,Karakhadi, Vadodara 391450, India.Manufactured by:Aleor Dermaceuticals Ltd.,Karakhadi, Vadodara 391450, India.Mfg. Lic. No.: G/25/2216

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