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NDC 42851-0037-80 ZO Skin Health Pigment Control Creme Hydroquinone 40 mg/mL Details

ZO Skin Health Pigment Control Creme Hydroquinone 40 mg/mL

ZO Skin Health Pigment Control Creme Hydroquinone is a TOPICAL EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ZO Skin Health, Inc.. The primary component is HYDROQUINONE.

Product Information

NDC	42851-0037
Product ID	42851-037_dd47af61-3b0f-4e58-e053-2995a90a7d9c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ZO Skin Health Pigment Control Creme Hydroquinone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydroquinone
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	EMULSION
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/mL
Substance Name	HYDROQUINONE
Labeler Name	ZO Skin Health, Inc.
Pharmaceutical Class	Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42851-0037-80 (42851003780)

Pricing Information	N/A
NDC Package Code	42851-037-80
Billing NDC	42851003780
Package	1 BOTTLE, PLASTIC in 1 CARTON (42851-037-80) / 80 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 83e34a75-d20c-43ab-be31-f8fcafec46d0 Details

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.

Principal Display Panel - 80 mL Bottle Carton

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/15/2018

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