NDC 70512-033 Halobetasol Propionate

Halobetasol Propionate Ointment

NDC Product Code 70512-033

NDC Code: 70512-033

Proprietary Name: Halobetasol Propionate Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Halobetasol Propionate Ointment Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 70512 - Kbs Solutions
    • 70512-033 - Halobetasol Propionate

NDC 70512-033-50

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE

NDC Product Information

Halobetasol Propionate with NDC 70512-033 is a a human prescription drug product labeled by Kbs Solutions. The generic name of Halobetasol Propionate is halobetasol propionate ointment. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Kbs Solutions

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat 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.


Halobetasol Propionate Active Ingredient(s)

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

  • HALOBETASOL PROPIONATE .5 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALUMINUM STEARATE (UNII: U6XF9NP8HM)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALLYL PENTAERYTHRITOL (UNII: 8S4V89348V)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • MONOSTEARYL CITRATE (UNII: YWW937R1QR)
  • YELLOW WAX (UNII: 2ZA36H0S2V)

Administration Route(s)

Additional informationCallout TooltipWhat 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.

Pharmacological Class(es)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kbs Solutions
Labeler Code: 70512
FDA Application Number: ANDA209978 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-04-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Halobetasol Propionate Product Label Images

Halobetasol 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

Description

Halobetasol Propionate Ointment, 0.05% contains halobetasol propionate, a synthetic corticosteroid

for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids

used topically as an anti-inflammatory and antipruritic agent.

Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-

1, 4-diene-3-20-dione, 17-propionate, C H ClF O . It has the following structural formula:
Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in

water.

Each gram of Halobetasol Propionate Ointment contains 0.5 mg/g of halobetasol propionate in a base of

aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan

sesquioleate, and stearyl citrate.

Clinical Pharmacology

Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and

vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids,

in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase

A 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 A
2 .
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors

including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with

hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however,

occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can

be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may

increase percutaneous absorption.

Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters

the circulation within 96 hours following topical administration of the ointment.

Studies performed with Ultravate Ointment indicate that it is in the super-high range of potency as

compared with other topical corticosteroids.

Indication And Usage

Halobetasol Propionate Ointment, 0.05% is a super-high potency corticosteroid indicated for the relief

of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment

beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week

because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in

children under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been

achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Contraindications

Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to

any of the components of the preparation.

Precautions

General
Systemic absorption of topical corticosteroids can produce reversible hypothalamic- pituitary-adrenal

(HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of

treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced

in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be

evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH

stimulation, A.M. plasma cortisol, and urinary free-cortisol tests. Patients receiving super potent

corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be

treated at any one time due to the increased risk of HPA suppression.

Halobetasol Propionate Ointment produced HPA axis suppression when used in divided doses at 7

grams per day for one week in patients with psoriasis. These effects were reversible upon

discontinuation of treatment.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the

frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is

generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of

glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For

information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their

larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

If irritation develops, Halobetasol Propionate Ointment should be discontinued and appropriate therapy

instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to

heal rather than noting a clinical exacerbation as with most topical products not containing

corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or anti-bacterial agent

should be used. If a favorable response does not occur promptly, use of Halobetasol Propionate

Ointment should be discontinued until the infection has been adequately controlled.

Halobetasol Propionate Ointment should not be used in the treatment of rosacea or perioral dermatitis,

and it should not be used on the face, groin, or in the axillae.
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:

1) The medication is to be used as directed by the physician. It is for external use only. Avoid contact

with the eyes.

2) The medication should not be used for any disorder other than that for which it was prescribed.

3) The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive

unless directed by the physician.

4) Patients should report to their physician any signs of local adverse reactions.
Laboratory Tests
The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH-stimulation

test; A.M. plasma cortisol test; Urinary free-cortisol test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol

propionate.

Positive mutagenicity effects were observed in two genotoxicity assays. Halobetasol propionate was

positive in a Chinese hamster micronucleus test, and in a mouse lymphoma gene mutation assay in vitro.

Studies in the rat following oral administration at dose levels up to 50 μg/kg/day indicated no

impairment of fertility or general reproductive performance.

In other genotoxicity testing, halobetasol propionate was not found to be genotoxic in the

Ames/Salmonella assay, in the sister chromatid exchange test in somatic cells of the Chinese hamster, in

chromosome aberration studies of germinal and somatic cells of rodents, and in a mammalian spot test to

determine point mutations.
Pregnancy
Teratogenic effects: Pregnancy Category C

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 in laboratory animals.

Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when

given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits.

These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of Ultravate

Ointment. Halobetasol propionate was embryotoxic in rabbits but not in rats.

Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.

There are no adequate and well-controlled studies of the teratogenic potential of halobetasol

propionate in pregnant women. Halobetasol Propionate Ointment should be used during pregnancy only

if the potential benefit justifies the potential risk to the fetus.
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 Halobetasol Propionate Ointment is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of Halobetasol Propionate Ointment in pediatric patients have not been

established and use in pediatric patients under 12 is not recommended. 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 or after withdrawal of treatment. Adverse effects including

striae have been reported with inappropriate use of topical corticosteroids in infants and children.

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.
Geriatric Use
Of approximately 850 patients treated with Halobetasol Propionate Ointment in clinical studies, 21%

were 61 years and over and 6% were 71 years and over. No overall differences in safety or

effectiveness were observed between these patients and younger patients; and other reported clinical

experience has not identified differences in responses between the elderly and younger patients, but

greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate

Ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse

reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection,

telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash.

The following additional local adverse reactions are reported infrequently with topical corticosteroids,

and they may occur more frequently with high potency corticosteroids, such as Halobetasol Propionate

Ointment. These reactions are listed in an approximate decreasing order of occurrence: folliculitis,

hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis,

secondary infection, striae and miliaria.

To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441,

or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce

systemic effects (see PRECAUTIONS).

Dosage And Administration

Apply a thin layer of Halobetasol Propionate Ointment to the affected skin once or twice daily, as

directed by your physician, and rub in gently and completely.

Halobetasol Propionate Ointment is a super-high potency topical corticosteroid; therefore, treatment

should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other

corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen

within 2 weeks, reassessment of diagnosis may be necessary.

Halobetasol Propionate Ointment should not be used with occlusive dressings.

How Supplied

Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes:

15 g (NDC 52565-073-15)

50 g (NDC 52565-073-51)

Store Halobetasol Propionate Ointment between 15 C and 30 C (59 F and 86 F).

Manufactured by:

Teligent Pharma, Inc.

Buena, NJ 08310

C100425 Revised: 03/2018

Package Label

NDC 52565-073-15
Halobetasol Propionate

Ointment, 0.05%

For topical use only.

Not for use in eyes.

Net Wt. 15 g

Rx Only

Teligent Pharma, Inc.

* Please review the disclaimer below.

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