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.
Dosage And Administration
Apply 2 pumps (1g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)
Warnings
Keep out of reach of children. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions, including anaphylactic symptoms (e.g., hives, itching) and life-threatening or less-severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.
Sunburn Alert
This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.
Storage
Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
Active Ingredient
Hydroquinone 4%
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.
Other
Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Principal Display Panel - 80 Ml Bottle Carton
ZO® SKIN HEALTH
BY ZEIN OBAGI MD
PIGMENT CONTROL
CRÈME
4% Hydroquinone
RX ONLY
NDC 42851-037-80
80 mL / 2.7 Fl. Oz.
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