ACNE VANISHING GEL- 5%- benzoyl peroxide 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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Benzoyl Peroxide 5%

Water, Carbomer, Glycerin, Propylene Glycol, Ethoxydigiycol, Laureth-7, Polyacrylamide C13-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol

Acne Medication

treats acne and helps prevent new acne blemishes from forming

kills acne bacteria

Directions:

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

WARNINGS: For External Use Only

Other Information

Do not use

When using this product:

Consult a doctor if excessive irritation occurs

Acne Vanishing Gel 5% Label

ACNE VANISHING GEL- 5% 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
LAURETH-7 (UNII: Z95S6G8201)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70367-002-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
2NDC:70367-002-04120 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 finalpart333D08/26/2014
Labeler - Only Yourx, Inc. (089207519)

Revised: 1/2020
Document Id: 9cd56620-8bb5-1ff3-e053-2a95a90a6dbc
Set id: 72f6e761-d0c4-1a84-e053-2991aa0aad7c
Version: 2
Effective Time: 20200123
 
Only Yourx, Inc.