Package insert / product label
Dosage form: cream
Drug class: Topical depigmenting agents
Medically reviewed by Drugs.com. Last updated on Aug 1, 2022.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.
On This Page
- Clinical Pharmacology
- Indications and Usage
- Patient Counseling Information
- Drug Interactions
- Adverse Reactions/Side Effects
- Dosage and Administration
- How Supplied/Storage and Handling
Hydroquinone Cream Description
Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg of hydroquinone USP, in a vanishing cream base of aqua (water), BHT, cetyl alcohol, disodium EDTA, glycerin, glycolic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tetrahexyldecyl ascorbate, and tocopheryl acetate. 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:
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.
INDICATIONS & USAGE
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.
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.
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.
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.
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.
DOSAGE & ADMINISTRATION
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.
How is Hydroquinone Cream Supplied
Hydroquinone USP, 4% Skin Bleaching Cream is available as follows:
1 oz (28.4 g) tube (NDC 75834-137-01)
Hydroquinone USP, 4% Skin Bleaching Cream should be stored at controlled room temperature (20-25°C) (68-77°F). Darkening of this product is normal.
This will not affect performance or safety.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.
1 DENTON C., LERNER A.B., FITZPATRICKT.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.
Nivagen Pharmaceuticals, Inc.
Sacramento, CA 95827 USA
Toll free number: 1-877-977-0687
Hydroquinone USP, 4%
Skin Bleaching Cream
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
28.4 g Tube Carton
|HYDROQUINONE 4% |
Labeler - Nivagen Pharmaceuticals, Inc. (052032418)
Nivagen Pharmaceuticals, Inc.
More about hydroquinone topical
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- En español
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Related treatment guides
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Can my doctor prescribe me hydroquinone? ›
Hydroquinone topical used to be available over the counter (OTC). But as a result of the 2020 CARES Act, it's only available by prescription from your provider.How can I get hydroquinone prescribed? ›
If you are interested in obtaining a high-strength prescription hydroquinone cream, talk to your dermatologist or healthcare provider today. Once you have a prescription we will be able to fill it and ship your cream directly to your home.Why did FDA ban hydroquinone? ›
The FDA has received reports of serious side effects from the use of hydroquinone, including rashes, facial swelling, and permanent skin discoloration (ochronosis).Can you prescribe hydroquinone cream? ›
Powerful skin-lightening creams are available on prescription from a doctor. These usually contain one or both of the following medicines: hydroquinone. topical steroids, such as hydrocortisone.What is the difference between hydroquinone prescription and OTC? ›
The main difference between prescription and OTC hydroquinone (when it was available) was the strength of the active ingredient. OTC formulations typically included up to 2% hydroquinone. Prescription formulations can be 4% or higher. Compounded formulations sometimes include 6, 8, or even 10% hydroquinone.How fast does prescription hydroquinone work? ›
It takes about four weeks on average for the ingredient to take effect. It may take several months of consistent use before you see full results.How strong is prescription hydroquinone? ›
Hydroquinone was available previously in over-the-counter products and is currently available in prescription formulations with common concentration ranges of 0.4 to 5%. Prescription strengths available in the United States include hydroquinone 2% and 4% cream and hydroquinone 2% gel.What is prescription strength hydroquinone? ›
In the United States, hydroquinone is classified as an over-the-counter (OTC) drug that may be used in concentrations of up to 2%. Most prescription-strength hydroquinone formulations contain 3–4%, but concentrations as high as 10% may be available through compounding pharmacies.What is the best alternative to hydroquinone? ›
Mequinol is the main alternative prescription alternative to hydroquinone. It's also known as methoxyphenol, hydroquinone monomethyl ether, and p-hydroxyanisole.
Prescription hydroquinone creams
Dermatologists can also check your skin condition to know the best treatment for you: the right concentration of ingredients, and how long you need to use it. They may also combine hydroquinone creams with other treatments, so you achieve faster results.
Why you should not use hydroquinone? ›
FDA has received reports of serious side effects including skin rashes, facial swelling, and ochronosis (discoloration of skin) from the use of skin lightening products containing hydroquinone.What are the dangers of using hydroquinone? ›
► Exposure can cause headache, nausea, vomiting, abdominal cramps, dizziness, and muscle twitching. ► Hydroquinone may cause a skin allergy. ► Long term exposure may affect the liver and kidneys.How long does prescription hydroquinone last? ›
A major key to hydroquinone is short-term use. You can slather it on twice daily for at least six weeks (and no more than six months). After one to three months, you should start to see your hyperpigmentation fade away. At the three-month mark, you should set it aside.Does hydroquinone lighten skin permanently? ›
Does hydroquinone lighten skin permanently? No, the results of any skin lightening that hydroquinone brings about are not permanent. The effects can be seen within a couple of months or a few years at the maximum.Is hydroquinone same as Retin A? ›
Retin-A cream is a form of vitamin A that helps the renovation of your skin. Hydroquinone is a bleaching cream that is used to lighten the skin tone and brown spots. Both products are used to keep enhancing your skin's color and glow after popular procedures like Botox or Acne treatments.What percentage hydroquinone is best? ›
In conclusion, hydroquinone is safe and effective when used as directed by a physician for a wide variety of pigmentation problems. To increase its efficacy and avoid unwanted side effects, dermatologists should consider the following protocol: Prescribe hydroquinone concentrations no higher than 4%.Can you put hydroquinone all over your face? ›
The authors instruct patients to apply a 4% hydroquinone topical cream to the entire face twice daily. Patients are cautioned against “spot treatment” to avoid developing a blotchy complexion.Is hydroquinone better in morning or night? ›
Apply Hydroquinone in the evening after Retin-A and in the morning for 2 to 6 weeks prior to the procedure. It helps to stop the production of pigment in the skin and will help prevent the skin from hyperpigmentation (darkening of your skin) after the procedure.What not to mix with hydroquinone? ›
Avoid using hydroquinone with peroxide products such as benzoyl peroxide or hydrogen peroxide, which can cause discoloration.How many times a day should you use hydroquinone? ›
Hydroquinone, a tyrosinase inhibitor, in a 4% cream can be used safely twice daily for up to 6 months to treat post-inflammatory hyperpigmentation. The efficacy of this treatment can be enhanced by using a retinoid nightly and a mid-potent steroid, which is applied twice daily for 2 weeks, then at weekends only.
Is hydroquinone once a day enough? ›
The lightening effects of prescription strength 4% hydroquinone are achieved with approximately four weeks of consistent, twice daily use. For those with mild hyperpigmentation, using once a day is typically enough to see results.Is hydroquinone covered by medical? ›
Do Medicare prescription drug plans cover hydroquinone? No. In general, Medicare prescription drug plans (Part D) do not cover this drug.Is hydroquinone covered by insurance? ›
It is an out of pocket expense as insurance will not cover this medication. If using it to treat melasma, it should be used in combination with a broad-spectrum sunscreen SPF 30 or higher daily. Sunscreen should be applied to the affected areas after hydroquinone to avoid relapse of the condition.What strength is prescription hydroquinone? ›
Hydroquinone was available previously in over-the-counter products and is currently available in prescription formulations with common concentration ranges of 0.4 to 5%. Prescription strengths available in the United States include hydroquinone 2% and 4% cream and hydroquinone 2% gel.What works just as good as hydroquinone? ›
Arbutin. According to Dr. Green, “Arbutin is a natural form of hydroquinone derived from the bearberry plant. It is a safer and effective alternative to hydroquinone and is less cytotoxic to the melanocytes.” Use it gradually during the first few weeks to make sure your skin doesn't react.Did FDA Ban hydroquinone? ›
In the case of hydroquinone, there is only one brand-name product that's FDA approved: Galderma Labs' Tri-Luma. Because hydroquinone is approved for use in that medication, it's included in the FDA's Orange Book — a list of drug substances and their therapeutic equivalents (a.k.a. generic substitutes).Do dermatologists recommend hydroquinone? ›
“Hydroquinone is considered the topical gold standard in dermatology for reducing hyperpigmentation.” Dermatologists often use hydroquinone to treat melasma, a skin condition where dark patches appear on the forehead, cheeks and upper lip.How much is the cost of hydroquinone? ›
The cost for hydroquinone topical topical cream 4% is around $41 for a supply of 28.35 grams, depending on the pharmacy you visit.What is stronger than hydroquinone? ›
Mequinol is the main alternative prescription alternative to hydroquinone. It's also known as methoxyphenol, hydroquinone monomethyl ether, and p-hydroxyanisole.Do dark spots come back after hydroquinone? ›
But over time, some of these consumers develop new pigment problems in the areas where they have faithfully applied hydroquinone. The product they bought to lighten sunspots, melasma, or other hyperpigmentation paradoxically leaves them with tough-to-treat issues such as severe rebound hyperpigmentation and ochronosis.
What to avoid when using hydroquinone? ›
Avoid peroxide products.
Avoid using hydroquinone with peroxide products such as benzoyl peroxide or hydrogen peroxide, which can cause discoloration.
Usage Recommendations. Hydroquinone can be used twice daily for up to five months consecutively. After five months, melanocytes should be allowed to stabilize during a two to three month break from hydroquinone.