Drugplain

Hydroquinone 4% 40 mg/g

Hydroquinone · CREAM · SOHM, Inc.

4 Recalls on Record
Plain English

Hydroquinone 4% is a cream containing hydroquinone at 40 mg/g, taken topical. Manufactured by SOHM, Inc..

Key Facts

Brand Name
Hydroquinone 4%
Generic Name
Hydroquinone
NDC Code (Product)
50405-800
Manufacturer
SOHM, Inc.
Strength
40 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Drug Class
Melanin Synthesis Inhibitor [EPC]
Marketing Start
06/05/2023

Recall History

4 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
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

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

squamous cell carcinoma of skin44 reports
drug ineffective43 reports
fatigue43 reports
pain41 reports
pruritus35 reports
product use in unapproved indication34 reports
off label use32 reports
condition aggravated31 reports
anxiety30 reports
arthralgia27 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND 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

DOSAGE AND 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

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

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

ADVERSE REACTIONS The following adverse reactions have been reported: dryness and fissuring of paranasal and intraorbital 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 4% used for?

Hydroquinone 4% contains Hydroquinone. It is a cream taken topical. Consult your doctor for specific uses.

Is Hydroquinone 4% a controlled substance?

Hydroquinone 4% is not classified as a controlled substance by the DEA.

What is the generic name for Hydroquinone 4%?

The generic name for Hydroquinone 4% is Hydroquinone. There are 10 other brand versions of Hydroquinone.

What is the NDC code for Hydroquinone 4% 40 mg/g?

The NDC (National Drug Code) for Hydroquinone 4% 40 mg/g is 50405-800, listed by SOHM, Inc..

Product NDC

50405-800

Package NDC

50405-800-01

Other Hydroquinone 4% Dosages

Other Hydroquinone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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