ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT- sulfur cream

ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT by

Drug Labeling and Warnings

ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT 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 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
• leave on for 10-15 minutes
• remove thoroughly with warm water, moist towels or cotton pads
• if bothersome dryness or peeling occurs, reduce application frequency as directed by your doctor.

Other information

• You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Inactive ingredients

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

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: 42851-073-85

OFFECTS®
SULFUR MASQUE
ACNE TREATMENT

Net Wt. 85 g / 3.0 Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-073
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ULTRAMARINE BLUE (UNII: I39WR998BI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-073-85	1 in 1 CARTON
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 42851-073-54	540 g in 1 CONTAINER; 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	05/01/2015

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(42851-073)