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 SunVanish (Hydroquinone USP, 4%) Skin Lightening Cream with Broad Spectrum SPF 25 contains 40 mg of Hydroquinone USP with 20 mg of Avobenzone, 75 mg of Octinoxate, 18.6 mg of Octocrylene, and 50 mg Oxybenzone in a cream base of Cetearyl Alcohol, Glycerin, Edetate Disodium, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate, Sodium Metabisulfite, and Sorbic Acid. The chemical name for hydroquinone 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 which may be prevented by the broad spectrum sunscreen agents contained in SunVanish.
Iii. Indications And Usage
Glytone SunVanish 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 SunVanish should be applied daily in the morning 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.Limit sunlight exposure during the day by applying an effective broad spectrum sunscreen (SPF 15 or higher) or by wearing sun-protective clothing to cover treated areas.
X. How Supplied
SunVanish is available as follows:Size NDC NumberNet Wt. 2 Oz. / 56 g tube 64760-401-02SunVanish should be stored at controlled room temperature 15° - 30° C (59° - 86° F). Do not expose to heat above 86° F or direct sunlight. Pierre Fabre logo Distributed by:Genesis Pharmaceutical, Inc.Parsippany, NJ 07054Made in U.S.A.1-800-GLYTONE (459-8663)www.glytone-usa.comRev. 062413
Principal Display - Glytone Sunvanish Carton 56 G
NDC 64760-702-01GLYTONE SunVanishSkin LighteningCreamBroad Spectrum Sunscreen SPF 25BRIGHTENING4% Hydroquinone, USPRx Only NET WT. 56.7 g / 2 OZ.GLYTONE SunVanish Skin Lightening Cream Carton
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