hydroquinone (Rx)

Brand and Other Names:

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Physicians may prescribe hydroquinone products through 503A and 503B compounding facilities

FDA alert explains there are no FDA-approved or otherwise legally marketed OTC skin lightening products

Melanin Hyperpigmentation

Used for gradual bleaching of hyperpigmented skin conditions (eg, chloasma, melisma, freckles, senile lentigines) and other unwanted areas of melanin hyperpigmentation

Apply sparingly to affected areas BID and rub in thoroughly

Generally 2-4% compounded topical creams are prescribed

Dosage Forms & Strengths

Physicians may prescribe hydroquinone products through 503A and 503B compounding facilities

FDA alert explains there are no FDA-approved or otherwise legally marketed OTC skin lightening products

Melanin Hyperpigmentation

Used for gradual bleaching of hyperpigmented skin conditions (eg, chloasma, melisma, freckles, senile lentigines) and other unwanted areas of melanin hyperpigmentation

Generally 2-4% compounded topical creams are prescribed

<12 years: Safety and efficacy not established

≥12 years: Apply sparingly to affected areas BID and rub in thoroughly

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Adverse Effects

Frequency Not Defined

Mild skin irritation and sensitization (burning, stinging)

Dermatitis

Dryness

Erythema

Inflammatory reaction

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Warnings

Contraindications

Hypersensitivity

Sunburn

Use as depilatory drug

Cautions

May contain sulfites that may cause allergic-type reactions

May cause skin rashes, facial swelling, and ochronosis

Avoid unnecessary exposure to sunlight

Limit application to areas no larger than arms, hands, face, and neck

Do not apply near eyes or mucous membranes, to cut, abraded, or sunburned skin, after shaving or using a depilatory agent; or over miliaria rubra (prickly heat)

Individuals with sensitive skin may experience temporary burning/stinging sensation

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Pregnancy & Lactation

Pregnancy

Unknown extent of systemic absorption

Lactation

Unknown if distributed in breast milk; use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Elicits reversible depigmentation of the skin by inhibiting enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA); also suppresses other melanocyte metabolic processes; sun exposure reverses effect and cause repigmentation

Pharmacokinetics

Onset and duration: Varies per individual

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
hydroquinone topical
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4 % cream
hydroquinone topical
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4 % cream
hydroquinone topical
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4 % cream

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
hydroquinone topical

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: Follow all directions on the product package, or use as directed by your doctor. 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.Tell your doctor if your condition lasts or gets worse after 2 months.

SIDE EFFECTS: See also How to Use.Mild burning, stinging, redness, and dryness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has prescribed this medication, remember that your doctor 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 right away if you have any serious side effects, including: blistering, skin cracking, blue-black darkening of the skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using hydroquinone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, other skin conditions (such as eczema, psoriasis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature. Keep all medications 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.

Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.