ZO SKIN HEALTH PIGMENT CONTROL 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 Crème 4% Hydroquinone
National Drug Codes 42851-037-80, 42851-037-30

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.

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.

Principal Display Panel - 80 mL Bottle Carton
ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE 
hydroquinone emulsion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-037-801 in 1 CARTON04/15/2018
180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:42851-037-301 in 1 CARTON07/01/2018
230 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 other04/15/2018
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 4/2022
Document Id: dd47af61-3b0f-4e58-e053-2995a90a7d9c
Set id: 83e34a75-d20c-43ab-be31-f8fcafec46d0
Version: 4
Effective Time: 20220422
 
ZO Skin Health, Inc.