ZO Skin Health Pigment Control Program Plus Hydroquinone

Hydroquinone · KIT · ZO Skin Health, Inc.

No Recall History

Plain English

ZO Skin Health Pigment Control Program Plus Hydroquinone is a kit containing hydroquinone. Manufactured by ZO Skin Health, Inc..

Key Facts

Brand Name: ZO Skin Health Pigment Control Program Plus Hydroquinone
Generic Name: Hydroquinone
NDC Code (Product): 42851-200
Manufacturer: ZO Skin Health, Inc.
Dosage Form: KIT
Marketing Status
Marketing Start: 03/09/2021

Recall History

No Recall History

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 Pigment Control Creme is indicated in the gradual bleaching of hyperpigmentation, skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage & Administration

DRUG DOSAGE AND ADMINISTRATION A thin layer of Pigment Control Creme (Hydroquinone USP, 4%) should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks 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 Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product. 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. Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation 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. Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

Contraindications

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

Drug Interactions

Drug Interactions Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Adverse Reactions

Adverse Reactions The following 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 ZO Skin Health Pigment Control Program Plus Hydroquinone used for?

ZO Skin Health Pigment Control Program Plus Hydroquinone contains Hydroquinone. It is a kit taken as directed. Consult your doctor for specific uses.

Is ZO Skin Health Pigment Control Program Plus Hydroquinone a controlled substance?

ZO Skin Health Pigment Control Program Plus Hydroquinone is not classified as a controlled substance by the DEA.

What is the generic name for ZO Skin Health Pigment Control Program Plus Hydroquinone?

The generic name for ZO Skin Health Pigment Control Program Plus Hydroquinone is Hydroquinone. There are 12 other brand versions of Hydroquinone.

What is the NDC code for ZO Skin Health Pigment Control Program Plus Hydroquinone ?

The NDC (National Drug Code) for ZO Skin Health Pigment Control Program Plus Hydroquinone is 42851-200, listed by ZO Skin Health, Inc..

Product NDC

42851-200

Package NDC

42851-200-60

Other Hydroquinone Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)