Glytone Clarifying Sunvanish With Sunscreen

Glytone Clarifying Sunvanish With Sunscreen

Glytone Clarifying Sunvanish With Sunscreen Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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.

Glytone Clarifying Sunvanish With Sunscreen Manufacturers


  • Genesis Pharmaceutical, Inc.
    Glytone Clarifying Sunvanish With Sunscreen (Hydroquinone) Cream [Genesis Pharmaceutical, Inc.]

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