Hydroquinone

FDA Drug Information • Also known as: Hydro-Q, Hydroquinone, Hydroquinone 4%, Hydroquinone Cream, Nu-Derm Blender Skin Lightener And...

Brand Names: Hydro-Q, Hydroquinone, Hydroquinone 4%, Hydroquinone Cream, Nu-Derm Blender Skin Lightener And Blending, Nu-Derm Clear Skin Bleaching And Corrector, Obagi C Rx System C Clarifying Serum, Obagi-C Rx System C-Clarifying Serum Normal To Oily Skin Lightening Serum With Vitamin C, Obagi-C Rx System C-Therapy Night Skin Lightening With Vitamins C And E, Olivia Quido Blemish Eraser, Vivant True Tone, Vivant True Tone Forte, Zo Skin Health Pigment Control Creme Hydroquinone, Zo Skin Health Pigment Control Plus Blending Creme Hydroquinone, Zo Skin Health Pigment Control Plus Brightening Creme Hydroquinone Plus Vitamin C, Zo Skin Health Pigment Control Program Plus Hydroquinone
Dosage Form: POWDER
Product Type: BULK INGREDIENT

Description

Description Hydroquinone is 1,4-benzenediol. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C 6 H 6 O 2 ; molecular weight is 110.11 g per mol. The chemical structure is in the diagram. chemstructure

What Is Hydroquinone Used For?

INDICATIONS AND USAGE The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and Administration

DOSAGE AND ADMINISTRATION A thin application should be applied once or twice daily or as directed by a physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and physician notified immediately. To report SUSPECTED ADVERSE REACTIONS, contact Obagi Medical Products, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings and Precautions

WARNINGS

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 product.

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, the product should be discontinued and a physician consulted. Close patient supervision is recommended.

Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, the patient should rinse thoroughly with water and contact a physician.

Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The Obagi-C ® Rx System C-Therapy Night Cream 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 nonasthmatic people.

Contraindications

CONTRAINDICATIONS People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Pregnancy and Breastfeeding

Pregnancy 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 used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated.

Nursing Mothers It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

How Supplied

HOW SUPPLIED Obagi-C ® Rx System C-Clarifying Serum (Hydroquinone, USP 4%) for Normal to Dry Skin is available as follows: 1 fl. oz. (30 mL) bottle NDC 62032-106-10 Obagi-C ® Rx System C-Clarifying Serum (Hydroquinone, USP 4%) for Normal to Oily Skin is available as follows: 1 fl. oz. (30 mL) bottle NDC 62032-122-10 Obagi-C ® Rx System C-Therapy Night Cream (Hydroquinone, USP 4%) is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-105-36 Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.