ADVERSE REACTIONS SECTION.

Adverse Reactions. The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Topical application of hydroquinone produces 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. 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.

DESCRIPTION SECTION.

DESCRIPTION. Hydroquinone is 1, 4-benzendiol, with chemical formula of C6H6O2 and molecular weight of 110.11.The structural formula is:C6H6O2 Each gram of MELAMIN-C(TM) (Hydroquinone USP, 4%) Skin Bleaching Correcting Creme with 20% Vitamin contains Hydroquinone USP 40mg/gm in 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.. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DRUG DOSAGE AND ADMINISTRATION. thin layer of MELAMIN-C(TM) (Hydroquinone USP, 4%) Skin Bleaching Correcting Creme with 20% vitamin should be applied to the affected area twice daily or as directed by 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 physician.

DRUG INTERACTIONS SECTION.

Drug Interactions. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

HOW SUPPLIED SECTION.

HOW SUPPLIED. MELAMIN-C(TM) (Hydroquinone USP, 4%) Skin Bleaching Correcting Creme with 20% Vitamin is available as follows:2.99 Oz. (85 g) Bottle NDC 42851-034-851.19 Oz. (34 g) Bottle NDC 42851-034-34. STORAGE. Store at controlled room temperature: 15-30C (59-86F).

INDICATIONS & USAGE SECTION.

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

NURSING MOTHERS SECTION.

Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to nursing woman.

OVERDOSAGE SECTION.

Overdosage. There have been no system reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience transient skin reddening and mild burning sensation which does not preclude treatment.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 85 Bottle Carton. ZO(R)MEDICALBY ZEIN OBAGI MDNDC 42851-034-85MELAMIN-C(TM)Skin Bleaching &Correcting Cremewith 20% Vitamin CHydroquinone USP, 4%RX ONLYNet Wt. 85 / 2.99 Oz.. Principal Display Panel 85 Bottle Carton.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

PRECAUTIONS SECTION.

PRECAUTIONS. Test for skin sensitivity before using by applying small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.. Drug Interactions. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.. Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.. Pregnancy Category C. Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to pregnant woman only if clearly needed.. Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to nursing woman.. Pediatric Use. Safety and effectiveness for pediatric patients below the age of 12 years have not been established.. Adverse Reactions. The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.. Overdosage. There have been no system reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience transient skin reddening and mild burning sensation which does not preclude treatment.

PREGNANCY SECTION.

Pregnancy Category C. Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

RX ONLYFOR EXTERNAL USE ONLY: NOT FOR OPHTHALMIC USE.

STORAGE AND HANDLING SECTION.

STORAGE. Store at controlled room temperature: 15-30C (59-86F).

WARNINGS SECTION.

WARNINGS. Hydroquinone is 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, 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 physician or poison control center immediately.