NDC 64760-700 Glytone Skin Lightening

Hydroquinone

NDC Product Code 64760-700

NDC 64760-700-01

Package Description: 1 TUBE in 1 CARTON > 56 g in 1 TUBE

NDC Product Information

Glytone Skin Lightening with NDC 64760-700 is a a human prescription drug product labeled by Pierre Fabre Usa Inc.. The generic name of Glytone Skin Lightening is hydroquinone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pierre Fabre Usa Inc.

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.

Glytone Skin Lightening 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.

  • HYDROQUINONE 40 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SORBIC ACID (UNII: X045WJ989B)

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.

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

Product Labeler Information

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

Labeler Name: Pierre Fabre Usa Inc.
Labeler Code: 64760
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: 04-01-2010 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: 09-30-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Glytone Skin Lightening 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

I. Description

Each gram of Glytone Hydroquinone USP, 4% Skin Lightening Cream contains 40 mg of Hydroquinone USP in a cream base of Cetostearyl Alcohol, Glycerin, Mineral Oil, Petrolatum, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate, Sodium Metabisulfite, and Sorbic Acid. The chemical name for hydroquinon is: 1,4-benzenediol. The molecular formula is C6H6O2 and molecular weight is 110.11. Hydroquinone has the following structural formula:Structural formula

Ii. Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the treated areas.

Iii. Indications And Usage

Glytone Skin Lightening Cream is indicated for the gradual lightening of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Iv. Contraindications

Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Vi. Precautions

SEE WARNINGS

Vii. Adverse Reactions

No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately.Sensitivity to sodium metabisulfite is a potential. See WARNINGS.

Viii. Overdosage

There have been no systemic reactions 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, but indicates caution is warranted.

Ix. Drug Dosage And Administration

Glytone Skin Lightening Cream should be applied daily at night to affected areas and rubbed in well, or as directed by a physician. If no lightening effect is seen after 2 months of treatment, use of this product should be discontinued. During the day, avoid sunlight exposure to treated areas by using an effective broad spectrum sunscreen (SPF 15 or higher) or by wearing sun-protective clothing.

X. How Supplied

Glytone Hydroquinone USP, 4% Skin Lightening Cream is available as followsSize       NDC NumberNET WT. 2 OZ. / 56 g tube       64760-700-01Store at room temperature of 68-77° F (20-25° C). Do not expose to heat above 86° F (30° C) or direct sunlight.Pierre Fabre logoDistributed by:Genesis Pharmaceutical, Inc.Parsippany, NJ 07054 U.S.A.1-800-GLYTONE (459-8663)www.glytone-usa.comRev. 121517

* Please review the disclaimer below.