PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE- benzoyl peroxide soap 
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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Inactive Ingredients: Water, Sodium C14-16 Alpha Olefin Sulfonate, Microcrystalline Cellulose, Disodium, Cocoamphodiacetate, Glycerin, ethoxydiglycol, Acrylates C10-30 Alkyl Acrylates Crosspolymer, Potassium Sorbate, Polysorbate 20, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol

Active Ingredients: Benzoyl Peroxide 2.5%

Purpose: Acne Medication; a gentle medicated exfoliant wash

Uses: Treats acne and helps prevent new acne blemishes from forming, kills acne bacteria

WARNINGS: For External Use Only

Do not use: if you have very sensitive skin; if you are sensitive to benzoyl peroxide

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 te 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: use 1 to 3 times daily on affected areaws to help prevent breakouts; apply using fingertips, using circular motions; gently scrub into a lather; rinse off thorouhly with warm water; if going outside, use a sunscreen

Other Information: store at room temperature; keep tightly closed

Pumice Cleansing Scrub 2.5%

PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE 
benzoyl peroxide soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70367-004-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
2NDC:70367-004-08240 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
3NDC:70367-004-7522.18 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: 9cd58ce4-747c-9225-e053-2995a90a501c
Set id: 270814fa-0109-6262-e054-00144ff8d46c
Version: 2
Effective Time: 20200123
 
Only Yourx, Inc.