Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Pigment Control Creme (Hydroquinone USP, 4%) is available as follows: 2.7 Fl. Oz. (80 mL) Bottle / NDC 42851-037-80 1.0 fl oz/30 ml Bottle / NDC 42851-037-30 STORAGE Store at controlled room temperature: 15°-30°C (59°-86°F); HOW SUPPLIED Pigment Control + Blending Creme (Hydroquinone USP, 4%) is available as follows: 2.7 Fl. Oz. (80 mL) Bottle / NDC 42851-036-80 1.0 Fl. Oz (30 mL) Bottle / NDC 42851-036-30 STORAGE Store at controlled room temperature: 15°-30°C (59°-86°F); PRINCIPAL DISPLAY PANEL - Kit Carton ZO ® SKIN HEALTH BY ZEIN OBAGI MD PIGMENT CONTROL PROGRAM + HYDROQUINONE NDC 42851-184-60 GENTLE CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz. COMPLEXION RENEWAL PADS 30 Pads PIGMENT CONTROL CRÈME 30 mL / 1.0 Fl. Oz. DAILY POWER DEFENSE 30 mL / 1 Fl. Oz. PIGMENT CONTROL + BLENDING CREME 30 mL / 1 Fl. Oz. US Pigment Control + Hydroquinone Kit UC.jpg
- HOW SUPPLIED Pigment Control Creme (Hydroquinone USP, 4%) is available as follows: 2.7 Fl. Oz. (80 mL) Bottle / NDC 42851-037-80 1.0 fl oz/30 ml Bottle / NDC 42851-037-30 STORAGE Store at controlled room temperature: 15°-30°C (59°-86°F)
- HOW SUPPLIED Pigment Control + Blending Creme (Hydroquinone USP, 4%) is available as follows: 2.7 Fl. Oz. (80 mL) Bottle / NDC 42851-036-80 1.0 Fl. Oz (30 mL) Bottle / NDC 42851-036-30 STORAGE Store at controlled room temperature: 15°-30°C (59°-86°F)
- PRINCIPAL DISPLAY PANEL - Kit Carton ZO ® SKIN HEALTH BY ZEIN OBAGI MD PIGMENT CONTROL PROGRAM + HYDROQUINONE NDC 42851-184-60 GENTLE CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz. COMPLEXION RENEWAL PADS 30 Pads PIGMENT CONTROL CRÈME 30 mL / 1.0 Fl. Oz. DAILY POWER DEFENSE 30 mL / 1 Fl. Oz. PIGMENT CONTROL + BLENDING CREME 30 mL / 1 Fl. Oz. US Pigment Control + Hydroquinone Kit UC.jpg
Overview
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 Pigment Control Creme (Hydroquinone USP, 4%) contains Hydroquinone USP 40 mg/gm in a base of Purified Water, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract. Chemical Structure DESCRIPTION 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 Pigment Control + Blending Creme contains Hydroquinone USP 40mg/gm in a base of Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Purified Water, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract. Chemical Structure
Indications & Usage
Pigment Control Creme is indicated in the gradual bleaching of hyperpigmentation, skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. 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.
Dosage & Administration
DRUG DOSAGE AND ADMINISTRATION A thin layer of Pigment Control Creme (Hydroquinone USP, 4%) 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. DRUG DOSAGE AND ADMINISTRATION A thin application of Pigment Control + Blending Creme should be applied to the affected area twice daily or as directed by a physician. Consult product label for instructions on whether to rub in or not. There is no recommendation for children under 12 years of age except under the advice and supervision of a physician.
Warnings & Precautions
WARNINGS 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. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. 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 non-asthmatic people. 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 this 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. WARNINGS 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. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. 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 non-asthmatic people. 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 this 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.
Contraindications
Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established. 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 (12 years and under) has 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. 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.
Drug Interactions
Patients are cautioned on concomitant use of medications that are known to be photosensitizing. Drug Interactions Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Storage & Handling
STORAGE Store at controlled room temperature: 15°-30°C (59°-86°F) STORAGE Store at controlled room temperature: 15°-30°C (59°-86°F)
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