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Hydroquinone USP, 4% | Hydroquinone [TWi Pharmaceuticals, Inc.] | BioPortfolio

12:40 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Skin Bleaching 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 glyceryl monostearate, mineral oil, PEG-25 propylene glycol stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, sodium metabisulfite, squalane and stearic acid. Chemically, hydroquinone is CHO 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) 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 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)

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. 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.

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 for 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 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 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

Rx Only

NDC 24979-141-36

Hydroquinone USP, 4%

Skin Bleaching Cream

Net Wt 1 oz (28.35 g)

Rx Only

NDC 24979-141-36

Hydroquinone USP, 4%

Skin Bleaching Cream

Net Wt 1 oz (28.35 g)

Manufacturer

TWi Pharmaceuticals, Inc.

Active Ingredients

Source

Clinical Trials [10 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 ...

Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.

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.

A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

PubMed Articles [28 Associated PubMed Articles listed on BioPortfolio]

Benzene metabolite hydroquinone promotes DNA homologous recombination repair via the NF-κB pathway.

Benzene, a widespread environmental pollutant, induces DNA double-strand breaks (DSBs) and DNA repair, which may further lead to oncogenic mutations, chromosomal rearrangements and leukemogenesis. How...

Effects of hydroquinone-containing creams on capillary glycemia before and after serial hand washings in Africans.

Hydroquinone-containing creams cause false increases in capillary glycemia. However, the magnitude of this false increase, and the means to reverse it have not been investigated.

Effective Tyrosinase Inhibition by Thiamidol Results in Significant Improvement of Mild to Moderate Melasma.

Melasma is a pigmentary disorder characterized by hyperpigmented patchy skin in sun-exposed areas, especially the face. Treatment of melasma can be challenging since long-term therapy is required, reo...

A Stereodynamic Redox-Interconversion Network of Vicinal Tertiary and Quaternary Carbon Stereocenters in Hydroquinone-Quinone Hybrid Dihydrobenzofurans.

Reversible redox processes involving hydroquinones and quinones are ubiquitous in biological reaction networks, materials science, and catalysis. While extensively studied in intermolecular settings, ...

Voltammetric simultaneous determination of catechol and hydroquinone using a glassy carbon electrode modified with a ternary hybrid material composed of reduced graphene oxide, magnetite nanoparticles and gold nanoparticles.

An electrochemical sensor is described for the simultaneous determination of the pollutants catechol (CC) and hydroquinone (HQ). A glassy carbon electrode (GCE) was modified with reduced graphene oxid...

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