NDC 72864-562 Olivia Quido Firm And Fade I

Hydrocortisone, Hydroquinone, Tretinoin

NDC Product Code 72864-562

NDC Code: 72864-562

Proprietary Name: Olivia Quido Firm And Fade I What 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: Hydrocortisone, Hydroquinone, Tretinoin What 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.

NDC Code Structure

  • 72864 - O Skin Pharmaceutical Corporation

NDC 72864-562-01

Package Description: 1 BOTTLE, DISPENSING in 1 BOX > 28.35 g in 1 BOTTLE, DISPENSING

NDC Product Information

Olivia Quido Firm And Fade I with NDC 72864-562 is a a human prescription drug product labeled by O Skin Pharmaceutical Corporation. The generic name of Olivia Quido Firm And Fade I is hydrocortisone, hydroquinone, tretinoin. The product's dosage form is cream and is administered via topical form.

Labeler Name: O Skin Pharmaceutical Corporation

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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 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.

Olivia Quido Firm And Fade I 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.

  • HYDROCORTISONE .01 g/g
  • HYDROQUINONE .08 g/g
  • TRETINOIN .001 g/g

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.

  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • CHLOROKOJIC ACID (UNII: UB7QQW2D47)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • PENTACLETHRA MACROLOBA SEED OIL (UNII: OM0BAV5397)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • LAURETH-7 (UNII: Z95S6G8201)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
  • PETROLATUM (UNII: 4T6H12BN9U)

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.

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)
  • Melanin Synthesis Inhibitor - [EPC] (Established Pharmacologic Class)
  • Melanin Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Depigmenting Activity - [PE] (Physiologic Effect)
  • Retinoid - [EPC] (Established Pharmacologic Class)
  • Retinoids - [CS]

Product Labeler Information

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

Labeler Name: O Skin Pharmaceutical Corporation
Labeler Code: 72864
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-09-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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’.

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Olivia Quido Firm And Fade I Product Label Images

Olivia Quido Firm And Fade I 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

Indications & Usage

INDICATIONS AND USAGE1.1IndicationOLIVIA QUIDO FIRM & FADE I Cream is a combination of hydrocortisone (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and a tretinoin (a retinoid) that is indicated for the gradual bleaching of hyperpigmented skin conditions age and liver spots, freckles, and other unwanted areas of melanin hyperpigmentation, in the presence of measures for sun avoidance, including the use of sunscreen.1.2 Limitations of UseThe safety and efficacy of OLIVIA QUIDO FIRM & FADE I Cream in pregnant women and nursing mothers have not been established.

Dosage & Administration

DOSAGE AND ADMINISTRATIONGently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of OLIVIA QUIDO FIRM & FADE I Cream to the affected area once daily at night or as directed by a doctor.During the day, use O Skin Sunscreen SPF-50, and wear protective clothing. Avoid sunlight exposure to prevent repigmentation.OLIVIA QUIDO FIRM & FADE I Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Dosage Forms & Strengths

3 DOSAGE FORMS AND STRENGTHSCream, 1%/8%/0.1%.Each gram of OLIVIA QUIDO FIRM & FADE I Cream contains 10.0 mg of hydrocortisone, 80.0 mg of hydroquinone, and 1.0 mg of tretinoin in a light yellow, hydrophilic cream base.

Contraindications

OLIVIA QUIDO FIRM & FADE I Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.

Warnings And Precautions

5 WARNINGS AND PRECAUTIONS5.1 HypersensitivityIf anaphylaxis, asthma or other clinically significantly hypersensitivity reactions occur, institute appropriate therapy and discontinue OLIVIA QUIDO FIRM & FADE I Cream. Allergic contact dermatitis may also occur.Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring.5.2 Exogenous OchronosisOLIVIA QUIDO FIRM & FADE I Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. Most patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.5.3. Effects on Endocrine SystemManifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while treatment. If HPA axis suppression is noted, the use of OLIVIA QUIDO FIRM & FADE I Cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.5.4 Cutaneous ReactionsOLIVIA QUIDO FIRM & FADE I Cream contains hydroquinone and tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, discontinue use of the medication and call a doctor.Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentrations of alcohol and astringents, and other irritants or keratolytic drugs while on OLIVIA QUIDO FIRM & FADE I Cream treatment. Avoid use of medications that are known to be photosensitizing.

Adverse Reactions

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately.

Drug Interactions

7 DRUG INTERACTIONSPatients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentration of alcohol and astringent, and other irritants or keratolytic drugs while on OLIVIA QUIDO FIRM & FADE I Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Use In Specific Populations

8 USE IN SPECIFIC POPULATIONS8.1 PregnancyTeratogenic Effects: Pregnancy Category CIn general, use of drugs should be reduced to a minimum in pregnancy. If a patient has been inadvertently exposed to OLIVIA QUIDO FIRM & FADE I Cream in pregnancy, she should be counseled on the risk of teratogenesis due to this exposure. The risk of teratogenesis due to topical exposure to OLIVIA QUIDO FIRM & FADE I Cream may be considered low. However, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy.Tretinoin is considered to be highly teratogenic upon systemic administration. Animal reproductive studies are not available with topical hydroquinone. 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.8.3 Nursing MothersCorticosteroids, when systemically administered, appear in human milk. It is not known whether topical application of OLIVIA QUIDO FIRM & FADE I Cream could result in sufficient systemic absorption to produce detectable quantities of hydrocortisone, hydroquinone, or tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when OLIVIA QUIDO FIRM & FADE I Cream is administered to a nursing woman. Care should be taken to avoid contact between the infant being nursed and OLIVIA QUIDO FIRM & FADE I Cream.8.4 Pediatric UseSafety and effectiveness of OLIVIA QUIDO FIRM & FADE I Cream in pediatric patients have not been established.8.5 Geriatric UseIn general, dose selection for an elderly patient should be cautious, 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.

Overdosage

10 OVERDOSAGEThere have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

Description

11 DESCRIPTIONOLIVIA QUIDO FIRM & FADE I Cream contains 1% of hydrocortisone, USP, 8% of hydroquinone, USP, and 0.1% of tretinoin, USP, in a light yellow, hydrophilic cream base for topical application.Hydrocortisone is a white to practically white crystalline powder. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11, 17,21-trihydroxy-, (11β)-. Its molecular formula is C21H30O5 ; its molecular weight is 362.46; its Chemical Abstract Service (CAS) registry number is 50-23-7. Hydroquinone is a melanin synthesis inhibitor. It is prepared from the reduction of p-benzoquinone with sodium bisulfite. It occurs as fine white needles that darken on exposure to air. The chemical name for hydroquinone is: 1,4-benzenediol. The molecular formula is C6H6O2 and molecular weight is 110.11. Tretinoin, a retinoid, is all-trans-retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. It occurs as yellow to light orange crystals or crystalline powder with a characteristic odor of ensilage. It is highly reactive to light and moisture. The chemical name for tretinoin is: (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. The molecular formula is C20H28O2 and molecular weight is 300.44. Tretinoin has the following structural formula:OLIVIA QUIDO FIRM & FADE I Cream contains Active: hydrocortisone 1% (10 mg), hydroquinone 8% (80 mg), and tretinoin 0.1% (1 mg). Inactive: aloe barbadensis leaf powder, ascorbic acid, BHT, C13-14 isoparaffin, caprylic/capric triglyceride, cetyl alcohol, cyclopentasiloxane, diazolidinyl urea, dimethicone crosspolymer, dimethyl isosorbide, ethylhexyl stearate, glycerin, iodopropynyl butylcarbamate, kojic acid, laureth-7, maltodextrin, PEG/PPG-18/18 dimethicone, pentaclethra macroloba seed oil, phenoxyethanol, polyacrylamide, polyacrylate-13, polyisobutene, polysorbate 20, polysorbate 80, propylene glycol, purified water, sodium lauryl sulfate, stearyl alcohol, tocopherol, tocopheryl acetate, triethylene glycol, white petrolatum.

Clinical Pharmacology

12 CLINICAL PHARMACOLOGY12.1 Mechanism of ActionThe mechanism of action of the active ingredients in OLIVIA QUIDO FIRM & FADE I Cream in the treatment of melasma is unknown.

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityCarcinogenesisStudies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.MutagenesisMutagenicity studies were not conducted with this combination of active ingredients. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay. Tretinoin has been shown to be negative for mutagenesis in the Ames assay. Additional information regarding the genetic toxicity potential of tretinoin is not available.Impairment of FertilityNo studies of fertility and early embryonic toxicity of this drug product has been performed.

How Supplied

16 HOW SUPPLIEDOLIVIA QUIDO FIRM & FADE I Cream is light yellow in color, and supplied in 28.35 g airless bottle, NDC 72864-562-01.

Storage And Handling

Storage: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) away from direct sunlight. KEEP REFRIGERATED.

Patient Counseling Information

17 PATIENT COUNSELING INFORMATIONSee FDA-approved patient labeling (Patient Information).Inform patients of the following:Advise patients to change to non-hormonal forms of birth control, if hormonal methods are used.Use OLIVIA QUIDO FIRM & FADE I Cream as directed by the health care provider and do not use OLIVIAQUIDO FIRM & FADE I Cream for any disorder other than that for which it is prescribed.Avoid exposure to sunlight, sunlamp, or ultraviolet light. Patients who are consistently exposed to sunlight orskin irritants either through their work environment or habits should exercise particular caution. Use sunscreenand protective covering (such as the use of a hat) over the treated areas. Sunscreen use is an essential aspectof melasma therapy, as even minimal sunlight sustains melanocytic activity.Weather extremes, such as heat or cold, may be irritating to patients treated with OLIVIA QUIDO FIRM & FADE I Cream. Because of the drying effect of this medication, a moisturizer may be applied to the face in the morning after washing.Keep OLIVIA QUIDO FIRM & FADE I Cream away from the eyes, nose, angles of the mouth, or open woundsbecause these areas are more sensitive to the irritant effect. If local irritation persists or becomes severe,discontinue application of the medication and consult your health care provider. Seek medical attention if youexperience allergic contact dermatitis, blistering, crusting, and severe burning or swelling of the skin and irritationof the mucous membranes of the eyes, nose, and mouth.If the medication is applied excessively, marked redness, peeling, or discomfort may occur.Wash your hands after each application.

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