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.
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.
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.
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.
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
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