ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE- hydroquinone emulsion

ZO Skin Health Pigment Control Creme Hydroquinone by

Drug Labeling and Warnings

ZO Skin Health Pigment Control Creme Hydroquinone by is a Prescription medication manufactured, distributed, or labeled by ZO Skin Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE 
hydroquinone emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42851-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)	Hydroquinone	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-037-80	1 in 1 CARTON	04/15/2018
1		80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 42851-037-30	1 in 1 CARTON	07/01/2018
2		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/15/2018

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	ANALYSIS(42851-037) , LABEL(42851-037) , MANUFACTURE(42851-037) , PACK(42851-037) , RELABEL(42851-037) , REPACK(42851-037)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		080095015	LABEL(42851-037) , MANUFACTURE(42851-037) , PACK(42851-037) , RELABEL(42851-037) , REPACK(42851-037)