Hydroquinone Cream

Name: Hydroquinone Cream

Hydroquinone Cream - 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.

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. To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing.

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 for pediatric patients below the age of 12 years have not been established.

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.

How is Hydroquinone Cream Supplied

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

1 oz (28.35 g) tube (NDC 24979-141-36)

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 for:

TWi pharmaceuticals USA, Inc.

Paramus, NJ 07652

Manufacured by:

Perrigo, Bronx, NY 10457

Rev 04-17

: 7J200 84 J1

Principal Display Panel - 1 oz Carton

Rx Only

NDC 24979-141-36

Hydroquinone USP, 4%

Skin Bleaching Cream

Net Wt 1 oz (28.35 g)

Principal Display Panel - 1 oz Tube

Rx Only

NDC 24979-141-36

Hydroquinone USP, 4%

Skin Bleaching Cream

Net Wt 1 oz (28.35 g)

HYDROQUINONE 
Hydroquinone Cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24979-141
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE  
MINERAL OIL  
POLYOXYL 40 STEARATE  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SODIUM METABISULFITE  
SQUALANE  
STEARIC ACID  
PEG-25 PROPYLENE GLYCOL STEARATE  
Product Characteristics
Color WHITE (white to off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:24979-141-36 1 TUBE in 1 CARTON
1 28.35 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/16/2017
Labeler - TWi Pharmaceuticals, Inc. (658402052)
Registrant - TWi Pharmaceuticals, Inc. (658402052)
Establishment
Name Address ID/FEI Operations
Perrigo New York Inc 078846912 manufacture(24979-141), analysis(24979-141), pack(24979-141)
Revised: 06/2017   TWi Pharmaceuticals, Inc.
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