Hydroquinone 4%
Hydroquinone · Cream · Topical
Uses
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.
Dosage and administration
Completely remove the foil seal. HYDROQUINONE 4% 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.
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
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
Drug Interactions - Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Pregnancy
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.
Pediatric use
Pediatric Use - Safety and effectiveness for pediatric patients below the age of 12 years have not been established.
Overdosage
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.
Description
Each gram of HYDROQUINONE 4% CREAM contains 40 mg hydroquinone, in a tan-colored cream base of Alcohol, Capryloyl Glycine, C13-14 Isoparaffin, Glycerin, Glycolic Acid, Kojic Acid, Laureth-7, Lecithin, Polyacrylamide, Purified Waters, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Squalane and Xanthan Gum. 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: Chemical Structure
How supplied
4% CREAM is available in a 1 oz (28.35 g) tube with (NDC 42192-151-01) Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]
Storage
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]
Patient information
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.
Label text from the FDA structured product label by Acella Pharmaceuticals, LLC (revised Jul 10, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hydroquinone in 5 products
Hydroquinone 4% NDC products (5)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 42192-151 | Hydroquinone 40 mg/g Cream | Acella Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 71399-0400 | Hydroquinone 40 mg/g Cream | Akron Pharma Inc | UNAPPROVED DRUG OTHER |
| 72162-2422 | Hydroquinone 40 mg/g Cream | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 75834-137 | Hydroquinone 40 mg/g Cream | Nivagen Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 50405-800 | Hydroquinone 40 mg/g Cream | SOHM, Inc. | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Hydroquinone 4% used for?
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.
What are the side effects of Hydroquinone 4%?
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. See the full label for the complete list.
Who makes Hydroquinone 4%?
Hydroquinone 4% is listed by 5 labelers in the FDA NDC directory, including Acella Pharmaceuticals, LLC, Akron Pharma Inc, Bryant Ranch Prepack, Nivagen Pharmaceuticals, Inc..