FDA Label for Zo Skin Health Pigment Control Creme Hydroquinone
View Indications, Usage & Precautions
Zo Skin Health Pigment Control Creme Hydroquinone Product Label
The following document was submitted to the FDA by the labeler of this product Zo Skin Health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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.
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