MEDPURA BENZOYL PEROXIDE- benzoyl peroxide liquid 
Akron Pharma 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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MEDPURA 5% and 10% Benzoyl Peroxide 
Acne Treatment Wash

Drug Facts

Active ingredient

Benzoyl peroxide 5% 

Benzoyl peroxide 10%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

When using this product

  • avoid unnecessary sun exposure and use a sunscreen.
  • avoid contact with eyes, lips, and mouth, eyelids and mucous membranes.
  • avoid contact with hair or dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.
  • irritation may be reduced by using the product less frequently or in a lower concentration.
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Other information

store at controlled room temperature, 15°- 30°C (59°- 86°F)

Inactive ingredients

citric acid, edetate disodium, germall 115, glycerin, phophomer x polymer, purified water, sodium olefin sulfonate, sodium hydroxide

Questions or comments?

call toll-free 1-877-225-6999

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ-07004
www.akronpharma.com

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MEDPURA BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-9234
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
ALCOHOL (UNII: 3K9958V90M)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE (UNII: 59RU860S8D)  
water (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-9234-5148 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2021
2NDC:71399-9234-8237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/04/2021
MEDPURA BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-9236
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
ALCOHOL (UNII: 3K9958V90M)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE (UNII: 59RU860S8D)  
water (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-9236-5148 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2021
2NDC:71399-9236-8237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/04/2021
Labeler - Akron Pharma Inc. (067878881)

Revised: 3/2023
Document Id: 164be820-6b36-411b-b37e-c965fb53122b
Set id: 1b051efe-054b-42a0-915a-b87885bd3c54
Version: 2
Effective Time: 20230310
 
Akron Pharma Inc.