Zo Skin Health Pigment Control Creme Hydroquinone
FDA Label NDC 42851-038

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zo Skin Health, Inc. for the product Zo Skin Health Pigment Control Creme Hydroquinone (NDC 42851-038). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Active Ingredient

Hydroquinone, 2%

Purpose

Skin Bleaching Agent

Uses

For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigments in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

For external use only.

Avoid contact with eyes.

Otc - Do Not Use

Do not use on children under 12 years of age unless directed by a doctor.

Otc - Stop Use

Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, seek medical help or contact a Poison Control Center right away.

Directions

  • Adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
  • Children under 12 years of age: do not use unless directed by a doctor.
  • Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Other Information

  • Store at a controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

Inactive Ingredients

Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

Questions?

5 Technology Dr. Irvine, CA 92618

Principal Display Panel - 80 Ml Bottle Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-038-80

PIGMENT CONTROL
CRÈME
2% Hydroquinone

80 mL / 2.7 Fl. Oz. U.S.

Principal Display Panel (80 mL Bottle Carton)

Principal Display Panel (80 mL Bottle Carton)

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