MEDPURA BENZOYL PEROXIDE AQUEOUS BASE, ACNE TREATMENT GEL- benzoyl peroxide gel

MEDPURA Benzoyl Peroxide by

Drug Labeling and Warnings

MEDPURA Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

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

SPL UNCLASSIFIED SECTION

Manufactured for:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDPURA BENZOYL PEROXIDE  AQUEOUS BASE, ACNE TREATMENT GEL
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-9478
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-9478-5	1 in 1 CARTON	09/13/2024
1		42.5 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71399-9478-6	1 in 1 CARTON	09/13/2024
2		60 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71399-9478-9	1 in 1 CARTON	09/13/2024
3		90 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/13/2024

MEDPURA BENZOYL PEROXIDE  AQUEOUS BASE, ACNE TREATMENT GEL
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-9474
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-9474-5	1 in 1 CARTON	09/13/2024
1		42.5 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71399-9474-6	1 in 1 CARTON	09/13/2024
2		60 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71399-9474-9	1 in 1 CARTON	09/13/2024
3		90 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/13/2024

Labeler - Akron Pharma Inc. (067878881)