Skin Lightening Moisturizing Cream

Rx Only

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Each gram of Hydroquinone USP, 4% Time Release Cream contains 40 mg hydroquinone USP and retinyl palmitate (vitamin A) incorporated into microspheres composed of acrylates/C10-30 alkyl acrylate crosspolymer. This polymeric system provides gradual release of active ingredient into the skin. Other ingredients include ascorbic acid (vitamin C), ascorbyl palmitate, ascorbyl tetraisopalmitate, benzyl alcohol, bisabolol, butylated hydroxytoluene, cetyl alcohol, cyclopentasiloxane, edetate disodium, ethylhexyl palmitate, glycerin, glyceryl monostearate, light mineral oil, phenoxyethanol, poloxamer 188, polyoxyl 40 stearate, propyl gallate, purified water, Simmondsia chinensis (Jojoba) seed oil, sodium metabisulfite, sorbitan tristearate, tocopheryl acetate (vitamin E), tricontanyl PVP, and trolamine. 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 the bleached areas (Parrish, J.A. et al., 1978)3.

Hydroquinone USP, 4% Time Release Cream is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration (such as chloasma, melasma, freckles, and senile lentigines) resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma.

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 on 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.

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% Time Release 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. Promptly tighten cap after each use. 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% Time Release Cream is available as follows:

30 g tube (NDC 24979-144-29)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

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.A., 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:

TWi Pharmaceuticals USA, Inc.

Paramus, NJ 07652

Manufactured by:

Perrigo, Bronx, NY 10457

Rev 04-17

: 5H700 84 J1

Rx Only

Hydroquinone Time Release Cream 4%

Skin Lightening Moisturizing Cream

NET WT 30 g