Each ml of Hydroquinone USP, 3% Topical Solution contains 30 mg of hydroquinone in a vehicle containing SD alcohol 40-B (45%), propylene glycol, laureth- 4, isopropyl alcohol (4%), purified water, and ascorbic acid. Chemically, hydroquinone is C₆H₆O₂ and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene.

Hydroquinone USP, 3% Topical Solution is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Hydroquinone USP, 3% Topical Solution should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. 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 during the day. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.

Hydroquinone USP, 3% Topical Solution is supplied in a 1 fly o (29 ml) plastic bottle with plastic rod and Dab-O-Matic® applicator NDC 59366-2781-3.
Store at controlled room temperature, 59°- 86° F (15°- 30° C).

CAUTION: Federal wlaw prohibits dispensing without prescription.

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.

No information provided.

General

For external use only. Avoid contact with eyes and mucous membranes.

Pregnancy

Category C - Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. 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 children below the age of 12 have not been established.

No information provided.

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.

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.

See CONTRAINDICATIONS and PRECAUTIONS.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

HYDROQUINONE - TOPICAL

(hi-dro-KWIN-own)

COMMON BRAND NAME(S): Eldoquin, Epiquin Micro, Lustra, Melanex

USES: Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin.

This medicine works by blocking the process in the skin that leads to discoloration.

HOW TO USE: Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. If the test area is itching, red, puffy, or blistering, do not use this product and contact your doctor. If there is just mild redness, then treatment with this product may begin.

Apply this medication to the affected areas of skin, usually twice daily or as directed by your doctor. This medication is for use on the skin only. If it is used incorrectly, unwanted skin lightening may occur. Avoid getting this product in your eyes or on the inside of your nose or mouth. If you do get this medication in those areas, flush with plenty of water.

This medication may make the treated areas of skin more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing on the treated areas of skin when outdoors.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Inform your doctor if your condition persists or worsens after 2 months.

SIDE EFFECTS: See also How to Use.

Mild burning, stinging, redness, and dryness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop using hydroquinone and tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, skin cracking, blue-black darkening of the skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using hydroquinone, tell your doctor or pharmacist if you are allergic to it; or to sulfites; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, other skin conditions (e.g., eczema, psoriasis).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms after swallowing may include: shaking (tremors), seizures.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another skin problem unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Different forms of this product have different storage temperatures. Consult your pharmacist or the product labeling for more information. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.