Drugplain

Hydroquinone cream 40 mg/g

Hydroquinone · CREAM · APNAR PHARMA LP

2 Recalls on Record
Plain English

Hydroquinone cream is a cream containing hydroquinone at 40 mg/g, taken topical. Manufactured by APNAR PHARMA LP.

Key Facts

Brand Name
Hydroquinone cream
Generic Name
Hydroquinone
NDC Code (Product)
24689-101
Manufacturer
APNAR PHARMA LP
Strength
40 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Drug Class
Melanin Synthesis Inhibitor [EPC]
Marketing Start
11/01/2021

Recall History

2 Recalls on Record
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

TerminatedVoluntary: Firm initiated
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

HYDROQUINONE USP, 4% SKIN BLEACHING 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 & Administration

HYDROQUINONE USP, 4% SKIN BLEACHING 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.

Warnings

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 non-asthmatic people. 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.

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.

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.

Frequently Asked Questions

What is Hydroquinone cream used for?

Hydroquinone cream contains Hydroquinone. It is a cream taken topical. Consult your doctor for specific uses.

Is Hydroquinone cream a controlled substance?

Hydroquinone cream is not classified as a controlled substance by the DEA.

What is the generic name for Hydroquinone cream?

The generic name for Hydroquinone cream is Hydroquinone. There are 12 other brand versions of Hydroquinone.

What is the NDC code for Hydroquinone cream 40 mg/g?

The NDC (National Drug Code) for Hydroquinone cream 40 mg/g is 24689-101, listed by APNAR PHARMA LP.