05:12 EDT 27th August 2014 | BioPortfolio
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Hydroquinone USP, 4% Skin Bleaching Cream with Sunscreens



Rx Only

Each gram of Hydroquinone USP, 4% Skin Bleaching Cream with Sunscreens contains 40 mg Hydroquinone USP, 30 mg Dioxybenzone USP, 20 mg Oxybenzone USP and 80 mg Padimate O USP in a vanishing cream base of ascorbic acid, ceteareth-20, cetostearyl alcohol, diethylaminoethyl stearate, dimethicone, edetate disodium, glyceryl dilaurate, glyceryl monostearate, hydroxyethyl cellulose, lactic acid, myristalkonium chloride, octyldodecyl stearoyl stearate, polysorbate 80, propylene glycol, purified water, quaternium-14, quaternium-26, sodium metabisulfite, and stearyl alcohol. 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:

IMAGE 92659b47-0793-406f-942a-70ba1c0c1718-01.jpg

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) and suppression of other melanocyte metabolic processes (Jimbow, K. et al., 1974). Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (Parrish, J.A. et al., 1978).

Hydroquinone USP, 4% Skin Bleaching Cream 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.

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.

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 Cream 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.

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.

Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. The suncreens 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.

Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

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.

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.

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.

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

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 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.

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

1 oz (28.35 g) tube (NDC 45802-975-64)

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



Inhibition of Melanin Formation by Chemical Agents

Journal of Investigative Dermatology 1952, 18:119-135.


Mechanism of Depigmentation by Hydroquinone

Journal of Investigative Dermatology 1974, 62:436-449.


UVA, Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet

Plenum Press, New York and London, 1978, p. 151.







Rev. 11/07


: 7C700 RC J1

Hydroquinone USP, 4%

Skin Bleaching Cream with Sunscreens

Rx Only

IMAGE 92659b47-0793-406f-942a-70ba1c0c1718-02.jpg

Hydroquinone USP, 4%

Skin Bleaching Cream with Sunscreens

Rx Only

IMAGE 92659b47-0793-406f-942a-70ba1c0c1718-03.jpg


Perrigo New York Inc

Active Ingredients


Clinical Trials [17 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study

To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from base...

Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women

This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream twice daily to affected areas on the face for 14 weeks and half the face will be peeled with ...

To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis

The purpose of this study is to compare safety and efficacy of Perrigo's drug compared to an FDA approved drug in the treatment of actinic keratosis.

To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis

The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.

Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Subjects With Moderate Facial Melasma

The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus 4% hydroquinone in the improvement of the appearance of moderate facial melasma.

PubMed Articles [37 Associated PubMed Articles listed on BioPortfolio]

Complementary effect of hydroquinone and retinoic acid on corneocyte desquamation with their combination use.

Retinoic acid (RA) enhances skin-lightening capabilities of hydroquinone (HQ), at least in part, by facilitating desquamation which leads to increase penetration of HQ. The desquamation also affects s...

Chemistry of Renieramycins. 17. A New Generation of Renieramycins: Hydroquinone 5-O-Monoester Analogues of Renieramycin M as Potential Cytotoxic Agents against Non-Small-Cell Lung Cancer Cells.

A series of hydroquinone 5-O-monoester analogues of renieramycin M were semisynthesized via bishydroquinonerenieramycin M (5) prepared from renieramycin M (1), a major cytotoxic bistetrahydroisoquinol...

Lack of pregnancy warnings on over-the-counter dermatologic products containing potentially harmful hydroquinone.

To determine the presence of pregnancy warnings on over-the-counter (OTC) dermatologic products with hydroquinone, a potentially harmful ingredient.

Catalytic Electrophilic Alkylation of p-Quinones via a Redox Chain Reaction.

Allylation and benzylation of p-quinones is achieved by an unusual redox chain reaction. Mechanistic studies suggest that the trace existence of hydroquinone initiates a redox chain reaction that cons...

Efficacy and safety of a novel picosecond laser using combination of 1 064 and 595 nm on patients with melasma: A prospective, randomized, multicenter, split-face, 2% hydroquinone cream-controlled clinical trial.

Melasma is a common acquired, chronic hypermelanosis and still remains a therapeutic challenge. The low-fluence 1 064 nm Q-switched Nd:YAG laser is the most widely used for the treatment of modera...

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