ZO SKIN HEALTH SULFUR MASQUE- sulfur cream

ZO Skin Health Sulfur Masque by

Drug Labeling and Warnings

ZO Skin Health Sulfur Masque by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Sulfur 10%

Purpose

Acne Treatment

Uses

• For the treatment of acne.
• Penetrates pores to clear most acne blemishes, blackheads, and whiteheads.
• Helps prevent new acne blemishes from forming.

Warnings

For external use only.

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
  If irritation occurs, only use one topical acne medication at a time.
• apply only to areas with acne.

Do not use on

• broken skin
• large areas of the skin

Keep out of reach of children.

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

Directions

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer twice a week.
• Suitable for use on face, chest, back or wherever breakouts occur.
• Leave on for 10-15 minutes and remove thoroughly with warm water, moist towels or cotton pads.
• If bothersome dryness or peeling occurs, reduce application frequency as directed by your doctor.
• As a spot treatment: apply a small amount onto the blemish and leave on overnight.

Inactive Ingredients

Water, Talc, Kaolin, Glycerin, Bentonite, Propylene Glycol, Caprylyl Glycol, Ethylene Brassylate, Silica, Tetrasodium EDTA, Phenoxyethanol, Chlorphenesin, Benzyl Alcohol, Ultramarines.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-089-85

SULFUR MASQUE
10% Sulfur

Net Wt. 85 g / 3 Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH SULFUR MASQUE 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-089
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Talc (UNII: 7SEV7J4R1U)
Kaolin (UNII: 24H4NWX5CO)
Glycerin (UNII: PDC6A3C0OX)
Bentonite (UNII: A3N5ZCN45C)
Propylene Glycol (UNII: 6DC9Q167V3)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylene Brassylate (UNII: 9A87HC7ROD)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Edetate Sodium (UNII: MP1J8420LU)
Phenoxyethanol (UNII: HIE492ZZ3T)
Chlorphenesin (UNII: I670DAL4SZ)
Benzyl Alcohol (UNII: LKG8494WBH)
Ultramarine Blue (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-089-85	1 in 1 CARTON	02/22/2019
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	02/22/2019

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(42851-089)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics, LLC.		007317209	MANUFACTURE(42851-089)