SOOTHING ANTISEPTIC MASK WITH SULFUR- sulfur cream

Soothing Antiseptic Mask with Sulfur by

Drug Labeling and Warnings

Soothing Antiseptic Mask with Sulfur by is a Otc medication manufactured, distributed, or labeled by Only Yourx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Sulfur 10%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Kaolin, Bentonite, Glycerin, Propylene Glycol, Magnesium Aluminum Silicate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Potassium Sorbate, Ethyl hexylglycerin, Phenoxyethanol

DOSAGE & ADMINISTRATION

Directions: apply thin coat over affe3cted area; leave on approximately 20 minutes until completely dry; rinse off with warm watre; use recommended toner to finish cleansing; purified water may be added for smoothr mask consistency

INDICATIONS & USAGE

Uses: treats acne and helps prevent new acne blemishes from forming

PURPOSE

acne mediaction; to treat and prevent acne

WARNINGS

Warnings: For External Use Only

WHEN USING

When using this product: do not use in or near eyes, lips, and mouth

ASK DOCTOR

Consult a doctor: if excessive irritation occurs

OTHER SAFETY INFORMATION

Other information: store at room temperature; keep tightly closed

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOOTHING ANTISEPTIC MASK WITH SULFUR 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
BENTONITE (UNII: A3N5ZCN45C)
GLYCERIN (UNII: PDC6A3C0OX)
2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-010-04	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-010-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
3	NDC: 70367-010-08	240 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/26/2014

Labeler - Only Yourx, Inc. (089207519)