SOOTHING ANTISEPTIC MASK WITH SULFUR- sulfur cream 
Only Yourx, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients: Sulfur 10%

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

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

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

acne mediaction; to treat and prevent acne

Warnings: For External Use Only

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

Consult a doctor: if excessive irritation occurs

Other information: store at room temperature; keep tightly closed

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

Soothing Antiseptic Mask with Sulfur

SOOTHING ANTISEPTIC MASK WITH SULFUR 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70367-010-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
2NDC:70367-010-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
3NDC:70367-010-08240 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/26/2014
Labeler - Only Yourx, Inc. (089207519)

Revised: 1/2020
Document Id: 9cd5746c-8c9d-918b-e053-2995a90ada7a
Set id: 7747b738-cfb8-0cf2-e053-2991aa0a031e
Version: 3
Effective Time: 20200123
 
Only Yourx, Inc.