ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE- hydroquinone lotion 
ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ZO ® Skin Health Pigment Control Creme 2% Hydroquinone
National Drug Code 42851-038-80

Drug Facts

Active Ingredient

Hydroquinone, 2%

Purpose

Skin Bleaching Agent

Uses

For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigments in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

For external use only.

Avoid contact with eyes.

Do not use on children under 12 years of age unless directed by a doctor.

Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Keep out of reach of children.

If swallowed, seek medical help or contact a Poison Control Center right away.

Directions

Other Information

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.

Questions?

5 Technology Dr. Irvine, CA 92618

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-038-80

PIGMENT CONTROL
CRÈME
2% Hydroquinone

80 mL / 2.7 Fl. Oz. U.S.

PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton
ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 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:42851-038-801 in 1 CARTON11/07/201809/23/2020
180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A11/07/2018
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 4/2022
Document Id: dd82a6af-aa21-98ba-e053-2995a90a5540
Set id: d9285ffa-6114-4798-9b16-169d2bb67355
Version: 2
Effective Time: 20220425
 
ZO Skin Health, Inc.