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.)
Zo Skin Health Pigment Control Plus Brightening Creme Hydroquinone Plus Vitamin C Emulsion
FDA Label NDC 42851-035
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 Plus Brightening Creme Hydroquinone Plus Vitamin C (NDC 42851-035). 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 dosage and administration, warnings, storage, active ingredient, inactive ingredients, other, principal display panel - 81 ml bottle carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Keep out of reach of children. 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.
Storage
Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
Active Ingredient
Hydroquinone 4%
Inactive Ingredients
Ascorbic Acid, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dimethicone Crosspolymer, Ethoxydiglycol, Helianthus Annuus (Sunflower) Seed Oil, Oleyl Alcohol, Plukenetia Volubilis Seed Oil, Retinyl Palmitate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Squalane, Tocopherol, Tocopheryl Acetate, Zanthoxylum Bungeanum Fruit Extract.
Other
Bleaches and corrects the most severe and advanced forms of hyperpigmentation in the skin with 4% hydroquinone and 20% vitamin C.
Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials zoskinhealth.com | 906000
Principal Display Panel - 81 Ml Bottle Carton
ZO® SKIN HEALTH
BY ZEIN OBAGI MD
PIGMENT CONTROL +
BRIGHTENING CRÈME
4% Hydroquinone
+ 20% Vitamin C
RX ONLY
NDC 42851-035-81
81 mL / 2.7 Fl. Oz.
Principal Display Panel (81 mL Bottle Carton)
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