Hydroquinone is a prescription medicine (Melanin Synthesis Inhibitor). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Brand names
- Hydro-Q, NU-DERM BLENDER Skin Lightener and Blending, NU-DERM CLEAR Skin Bleaching and Corrector, NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE, OBAGI C RX system C CLARIFYING SERUM, OBAGI-C Rx system C-CLARIFYING SERUM NORMAL TO oily SKIN LIGHTENING SERUM WITH VITAMIN C, Olivia Quido Blemish Eraser, Obagi-C Rx system C-Therapy Night Skin Lightening with Vitamins C and E
- Drug class
- Melanin Synthesis Inhibitor
- Taken
- Topical
- Label
- Acella Pharmaceuticals, LLC, revised July 10, 2026 · full label on DailyMed
- Generic
- No · details
What it is used for
HYDROQUINONE 4% 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.
Who should not take it (contraindications)
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.
Warnings
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.
Precautions
(see WARNINGS )
Side effects (adverse reactions)
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.
Drug interactions
– Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Pregnancy
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.
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.
Breastfeeding
– 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.
Use in children
– Safety and effectiveness for pediatric patients below the age of 12 years have not been established.
Is there a generic Hydroquinone?
No. The FDA has not approved a generic version yet.
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Hydroquinone in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 595dfc50-ee6f-41b5-ab5b-4c293aee342b.