ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE- hydroquinone emulsion 
ZO Skin Health, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ZO® Skin Health Pigment Control + Blending Crème 4% Hydroquinone
National Drug Codes 42851-036-80, 42851-036-30

Blending crème containing 4% hydroquinone, the optimal concentration for melanin inhibition to correct skin pigmentation disorders.

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

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.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials
zoskinhealth.com | 905700

PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton

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
ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE 
hydroquinone emulsion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.04 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-036-801 in 1 CARTON05/01/2018
180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:42851-036-331 in 1 CARTON05/01/201804/01/2019
233 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:42851-036-301 in 1 CARTON05/01/2018
330 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2018
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 4/2022
Document Id: dd473419-8217-5f56-e053-2995a90ad156
Set id: c29cbc80-cb97-42d0-b796-ee487b0e85c5
Version: 4
Effective Time: 20220422
 
ZO Skin Health, Inc.