GLYTONE CLARIFYING SUNVANISH WITH SUNSCREEN- hydroquinone cream
Genesis Pharmaceutical, Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
----------
Glytone Clarifying SunVanish with Sunscreen
I. DESCRIPTION
Each 1 gram dose of SunVanish contains 40 mg of Hydroquinone USP, 75 mg of Octinoxate, 50 mg of Oxybenzone, 20 mg of Avobenzone, and 18.6 mg of Octocrylene in a cream base of Purified Water, Propylene Glycol, Cetearyl Alcohol, Glycerin, Sodium Lauryl Sulfate, Isopropyl Palmitate, Sodium Metabisulfite, Sorbic Acid, and Disodium EDTA.
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
SunVanish is indicated for the gradual bleaching 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.
V. WARNINGS
A. CAUTION: Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
B. Test for skin sensitivity before using SunVanish by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response,further treatment is not advised. Close patient supervision is recommended. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with warm water and contact their physician. If no bleaching or lightening effect is noted after 2 months of treatment, SunVanish should be discontinued. SunVanish is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.
C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The sunscreens in SunVanish provide the necessary sun protection during skin bleaching therapy. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a broad spectrum sunscreen greater than SPF 15 and protective clothing to prevent repigmentation.
D. Keep this and all medication out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.
E. WARNING: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
VI. PRECAUTIONS
SEE WARNINGS
A. Pregnancy Category C. Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should not be used in pregnant women.
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 metabisulfate is a potential. See WARNINGS.
VIII. OVERDOSAGE
There have been no systemic reactions from the use of topical hydroquinone in SunVanish in recommended quantities. 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
SunVanish should be applied in the morning to the affected area and rubbed in well or as directed by your physician to achieve maximum therapeutic potential.
X. HOW SUPPLIED
SunVanish is available as follows:
Size NDC Number
Net Wt. 2 Oz. / 56 g tube 64760-401-02
SunVanish should be stored at controlled room temperature 15° - 30° C (59° - 86° F). Do not expose to heat above 86° F or direct sunlight.
Distributed by:
Genesis Pharmaceutical, Inc.
Parsippany, NJ 07054
Made in U.S.A.
1-800-GLYTONE (459-8663)
Rev. 062413
| GLYTONE CLARIFYING SUNVANISH WITH SUNSCREEN
hydroquinone cream |
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
| Labeler - Genesis Pharmaceutical, Inc. (117196928) |