Glytone Clarifying

Glytone Clarifying

Glytone Clarifying 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 Clarifying Cream 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, Clarifying Cream should be discontinued.

C. There are no sunscreening agents in Clarifying Cream and since minimal sunlight exposure may reverse the bleaching effect of this preparation, it should be used only at night or on areas of the body covered by protective clothing. During the daytime, broad spectrum sunscreen or protective clothing should be used to prevent the bleached areas from repigmentation. For daytime bleaching of unwanted pigmented areas, the use of Glytone SunVanish should be considered.

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

Clarifying Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. It is intended for night-time use only since it contains no sunscreen agents. For daytime usage, Glytone SunVanish should be prescribed.

History

There is currently no drug history available for this drug.

Other Information

Each 1 gram dose of Clarifying Cream contains 40 mg of Hydroquinone USP in a cream base of Purified Water, Cetostearyl Alcohol, Glycerin, Petrolatum, Propylene Glycol, Mineral Oil, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sorbic Acid.

Glytone Clarifying Manufacturers


  • Genesis Pharmaceutical, Inc.
    Glytone Clarifying (Hydroquinone) Cream [Genesis Pharmaceutical, Inc.]
  • Genesis Pharmaceutical, Inc.
    Glytone Clarifying (Hydroquinone) Gel [Genesis Pharmaceutical, Inc.]

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