MEDPURA BENZOYL PEROXIDE AQUEOUS BASE, ACNE TREATMENT GEL- benzoyl peroxide gel 
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 
Aqueous Base, Acne Treatment Gel

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

  • 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.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and 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.

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 20°-25°C (68°-77°F)

Inactive ingredients

docusate sodium, ethyl alcohol, methyl salicylate, phosphomer x polymer, purified water, sodium hydroxide

Questions or comments?

call toll-free 1-877-225-6999

Manufactured for:

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

5ml

10ml

MEDPURA BENZOYL PEROXIDE  AQUEOUS BASE, ACNE TREATMENT GEL
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-9478
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:71399-9478-51 in 1 CARTON11/04/2021
142.5 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:71399-9478-61 in 1 CARTON11/04/2021
260 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:71399-9478-91 in 1 CARTON11/04/2021
390 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/04/2021
MEDPURA BENZOYL PEROXIDE  AQUEOUS BASE, ACNE TREATMENT GEL
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-9474
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:71399-9474-51 in 1 CARTON11/04/2021
142.5 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:71399-9474-61 in 1 CARTON11/04/2021
260 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:71399-9474-91 in 1 CARTON01/01/2023
390 mL in 1 TUBE; Type 0: Not a Combination Product
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: 11d3cf69-6243-4de4-bba4-bb519eaf9c73
Set id: b7d335d1-3022-4b28-913c-477152a7dad2
Version: 2
Effective Time: 20230310
 
Akron Pharma Inc.