ACNE VANISHING GEL- 10% WITH SULFUR- benzoyl peroxide, sulfur gel 
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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WARNINGS: For External Use Only

Active Ingredients:

Benzoyl Peroxide 10%

Sulfur 3%

Treats acne and helps prevent new blemishes from forming

Kills acne bacteria

Do Not Use: if you have very sensitive skin

are sensitive to benzoyl peroxide or sulfur

When using this product

avoid sun exposure and use sunscreen

using other acne medications at the same time may cause excessive dryness or irritation of the skin

may bleach hair and fabrics

do not use in or near eyes, lips and mouth

Consult a doctor if excessive irritation occurs

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

Directions:

cleanse skin thoroughly before applying

cover entire affected area with thin layer 1 to 3 times daily

if excessive dryness or irritation occurs, reduce application to once a day or every oter day
if going outside, use a sunscreen

Other information

store at room temperature

keep tightly closed

Inactive Ingredients:

Water, Ethoxydiglycol, Cetyl Octanoate, Glyceryl Stearate, APEG-100 Stearate, Glycerin, Propylene Glycol, Cetearyl Alcohol, Ceteareth-20, Polyacrylamide C13-14 Isoparaffin, Laureth-7, Dimethicone, Potassium Sorbate, Polysorbate 20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Phenoxyethanol

To treat acne and reduce inflammation

Acne Vanishing Gel- 10% with Sulfur

ACNE VANISHING GEL- 10% WITH SULFUR 
benzoyl peroxide, sulfur gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETEARETH-22 (UNII: 28VZG1E234)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL OCTACOSANOATE (UNII: O7F4812VDX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
LAURETH-7 (UNII: Z95S6G8201)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70367-003-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
2NDC:70367-003-04120 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 finalpart333D03/28/2014
Labeler - Only Yourx, Inc. (089207519)

Revised: 1/2020
Document Id: 9cd58dcd-38fd-93a8-e053-2995a90a4c7d
Set id: 270814fa-0107-6262-e054-00144ff8d46c
Version: 2
Effective Time: 20200123
 
Only Yourx, Inc.