Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydroquinone USP, 4% Skin Bleaching Cream is available as follows: 1 oz (28.4 g) tube (NDC 75834-137-01) STORAGE Hydroquinone USP, 4% Skin Bleaching Cream should be stored at controlled room temperature (20-25°C) (68-77°F). Darkening of this product is normal. This will not affect performance or safety. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein. REFERENCES 1 DENTON C., LERNER A.B., FITZPATRICKT.B. Inhibition of Melanin Formation by Chemical Agents Journal of Investigative Dermatology 1952, 18:119-135. 2 JIMBOW K., OBATA H., PATHAK M., FITZPATRICK T.B. Mechanism of Depigmentation by Hydroquinone Journal of Investigative Dermatology 1974, 62:436-449. 3 PARRISH J.A., ANDERSON R.R., URBACH F., PITTS D. UVA, Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet Plenum Press, New York and London, 1978, p. 151. Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA Toll free number: 1-877-977-0687 Rev. 02/2022 Hydroquinone USP, 4% Skin Bleaching Cream; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 28.4 g Tube Carton tube.jpg
- HOW SUPPLIED Hydroquinone USP, 4% Skin Bleaching Cream is available as follows: 1 oz (28.4 g) tube (NDC 75834-137-01) STORAGE Hydroquinone USP, 4% Skin Bleaching Cream should be stored at controlled room temperature (20-25°C) (68-77°F). Darkening of this product is normal. This will not affect performance or safety. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein. REFERENCES 1 DENTON C., LERNER A.B., FITZPATRICKT.B. Inhibition of Melanin Formation by Chemical Agents Journal of Investigative Dermatology 1952, 18:119-135. 2 JIMBOW K., OBATA H., PATHAK M., FITZPATRICK T.B. Mechanism of Depigmentation by Hydroquinone Journal of Investigative Dermatology 1974, 62:436-449. 3 PARRISH J.A., ANDERSON R.R., URBACH F., PITTS D. UVA, Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet Plenum Press, New York and London, 1978, p. 151. Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA Toll free number: 1-877-977-0687 Rev. 02/2022 Hydroquinone USP, 4% Skin Bleaching Cream
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 28.4 g Tube Carton tube.jpg
Overview
Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg of hydroquinone USP, in a vanishing cream base of aqua (water), BHT, cetyl alcohol, disodium EDTA, glycerin, glycolic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tetrahexyldecyl ascorbate, and tocopheryl acetate. Chemically, hydroquinone is C 6 H 6 O 2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is: structure.jpg
Indications & Usage
INDICATIONS & USAGE Hydroquinone USP, 4% Skin Bleaching 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.
Dosage & Administration
DOSAGE & ADMINISTRATION Hydroquinone USP, 4% Skin Bleaching Cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months 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.
Warnings & Precautions
WARNINGS 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. Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation 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. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.
Contraindications
Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. The safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.
Adverse Reactions
The following adverse 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.
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