Perrigo Hydroquinone

Perrigo New York Inc

HYDROQUINONE USP, 4% SKIN BLEACHING GEL W/ SUNSCREENS

FULL PRESCRIBING INFORMATION: CONTENTS*

• PERRIGO HYDROQUINONE DESCRIPTION
• CLINICAL PHARMACOLOGY
• PERRIGO HYDROQUINONE INDICATIONS AND USAGE
• PERRIGO HYDROQUINONE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Information for Patients
  • Drug Interactions
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
• PERRIGO HYDROQUINONE ADVERSE REACTIONS
• OVERDOSAGE
• PERRIGO HYDROQUINONE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Principal Display Panel - 1 oz Carton
• Principal Display Panel - 1 oz Tube

FULL PRESCRIBING INFORMATION

Hydroquinone USP, 4%

Skin Bleaching Gel with Sunscreens

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Rx Only

PERRIGO HYDROQUINONE DESCRIPTION

Each gram of Hydroquinone USP, 4% Skin Bleaching Gel with Sunscreens contains 40 mg Hydroquinone USP, 30 mg Dioxybenzone USP, and 50 mg Padimate O USP in a hydroalcoholic base of alcohol (55%), carbomer 940, edetate disodium, propylene glycol, purified water, sodium metabisulfite, and tetrahydroxypropyl ethylenediamine. 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:

CLINICAL PHARMACOLOGY

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.

PERRIGO HYDROQUINONE INDICATIONS AND USAGE

Hydroquinone USP, 4% Skin Bleaching Gel with Sunscreens is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

PERRIGO HYDROQUINONE 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 in children (12 years and under) has not been established.

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.

Hydroquinone USP, 4% Skin Bleaching Gel with Sunscreens is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.

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.

PRECAUTIONS

(see WARNINGS)

General

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.

Information for Patients

Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. The sunscreens in this product provide the necessary sun protection during skin bleaching therapy. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent or protective clothing to prevent repigmentation.

Avoid contact with eyes and mucous membranes.

Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

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.

Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay.

Pregnancy

Teratogenic effects

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 a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a 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 a nursing woman.

Pediatric Use

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

PERRIGO HYDROQUINONE 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.

OVERDOSAGE

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.

PERRIGO HYDROQUINONE DOSAGE AND ADMINISTRATION

Hydroquinone USP, 4% Skin Bleaching Gel with Sunscreens 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.

HOW SUPPLIED

Hydroquinone USP, 4% Skin Bleaching Gel with Sunscreens is available as follows:

1 oz (28.35 g) tube (NDC 45802-982-64)

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

REFERENCES

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 BY

STIEFEL LABORATORIES, INC.

CORAL GABLES, FL 33134

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 11/07

81915

: 8F900 RC J1

Principal Display Panel - 1 oz Carton

Hydroquinone USP, 4%

Skin Bleaching Gel with Sunscreens

Rx Only

Principal Display Panel - 1 oz Tube

Hydroquinone USP, 4%

Skin Bleaching Gel with Sunscreens

Rx Only