Label: HYDROQUINONE cream

Rx only

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg hydroquinone USP, in a vanishing cream base of aqua (water), ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, glycolic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol and tocopheryl acetate. Chemically, hydroquinone is C6H6O2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is:

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) (Denton, C. et al., 1952)1 and suppression of other melanocyte metabolic processes (Jimbow, K. et al., 1974)2. Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (Parrish, J.A. et al., 1978)3.

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.

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.

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.

(see WARNINGS)

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.

There have been no systemic 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 a transient skin reddening and a mild burning sensation which does not preclude treatment.

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.

Hydroquinone USP, 4% Skin Bleaching Cream is available as follows:

1 oz (28.35 g) tube (NDC 72056-060-01)

1 DENTON C., LERNER A.B., FITZPATRICK T.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:
Syntenza Pharmaceuticals LLC
Edina, MN 55436, USA

Rev. 03/18

Hydroquinone USP, 4%
Skin Bleaching Cream

SYNTENZA

NDC 72056-060-01

Hydroquinone USP, 4% Skin Bleaching Cream

Net Wt. 1 oz. (28.35 g)

Rx Only