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 Blending Creme Hydroquinone (NDC 42851-036). 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, dosage and administration, warnings, sunburn alert, storage, active ingredient, inactive ingredients, principal display panel - 80 ml bottle carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Blending crème containing 4% hydroquinone, the optimal concentration for melanin inhibition to correct skin pigmentation disorders.
Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials
zoskinhealth.com | 905700
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.)
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.
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.
Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
Hydroquinone 4%
Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Water, Yucca Schidigera Root Extract.
ZO® SKIN HEALTH
BY ZEIN OBAGI MD
PIGMENT CONTROL +
BLENDING CRÈME
4% Hydroquinone
RX ONLY
NDC 42851-036-80
80 mL / 2.7 Fl. Oz.
Principal Display Panel (80 mL Bottle Carton)
* Please review the disclaimer below.
