ZO MEDICAL MELAMIN-C Skin Bleaching and Correcting with Vitamin C Hydroquinone

RX ONLY
FOR EXTERNAL USE ONLY:
NOT FOR OPHTHALMIC USE

Hydroquinone is 1, 4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.

The structural formula is:

Each gram of MELAMIN-C™ (Hydroquinone USP, 4%) Skin Bleaching & Correcting Crème with 20% Vitamin C contains Hydroquinone USP 40mg/gm in a base of ascorbic acid, ascorbyl palmitate, caprylic/capric triglyceride, caprylyl methicone, cetyl PEG/PPG-10/1 dimethicone, cyclotetrasiloxane, dimethicone, dimethicone crosspolymer, tocopheryl acetate, ethoxydiglycol, helianthus annuus (sunflower) seed oil, oleyl alcohol, pluenetia volubilis seed oil, retinyl palmitate, rosmarinus officinalis (rosemary) leaf extract, squalene, tocopherol, zanthoxylum bungeanum fruit extract.

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 re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

For the gradual bleaching of hyperpigmented skin conditions such as cholasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Prior history of sensitivity or allergic reaction to hydroquinone or to any other ingredient in this product. The safety of topical hydroquinone use during pregnancy or in children (21 years and under) has not been established.

Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product.

Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation from occurring.

Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If his condition occurs, discontinue treatment and consult your physician.

Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 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.

A thin layer of MELAMIN-C™ (Hydroquinone USP, 4%) Skin Bleaching & Correcting Crème with 20% vitamin C should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

MELAMIN-C™ (Hydroquinone USP, 4%) Skin Bleaching & Correcting Crème with 20% Vitamin C is available as follows:

2.99 Oz. (85 g) Bottle / NDC 42851-034-85

1.19 Oz. (34 g) Bottle / NDC 42851-034-34

ZO^®MEDICAL
BY ZEIN OBAGI MD

NDC 42851-034-85

MELAMIN-C™
Skin Bleaching &
Correcting Crème
with 20% Vitamin C

Hydroquinone USP, 4%

RX ONLY

Net Wt. 85 g / 2.99 Oz.