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.
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.
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.
Clarifying Cream should be applied nightly to the affected area and rubbed in well or as directed by your physician to achieve maximum therapeutic potential. During the day, an effective broad spectrum sunscreen should be used and unnecessary sun exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring.
Clarifying Gel should be applied nightly to the affected area and rubbed in well or as directed by your physician to achieve maximum therapeutic potential. During the day, an effective broad spectrum sunscreen should be used and unnecessary sun exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring.