BENZOYL PEROXIDE 5% TOPICAL WASH- benzoyl peroxide liquid BENZOYL PEROXIDE 10% TOPICAL WASH- benzoyl peroxide liquid

BENZOYL PEROXIDE 10% Topical wash by

Drug Labeling and Warnings

BENZOYL PEROXIDE 10% Topical wash by is a Otc medication manufactured, distributed, or labeled by Medcore LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

BENZOYL PEROXIDE 5% or 10%

Purpose

Acne medication

Uses

For the treatment of acne

Warnings

For external use ONLY. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. Avoid unnessary sun exposure and use a sunscreen. Avoid contact with eyes, lips and mouth. Avoid contact with hair,dyed fabrics, which may be bleached by thisproduct. 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 lower concentration.If irritation or sensitivy develops stop use of both products and ask a doctor.

INSTRUCTIONS FOR USE

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, 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

• - allergic reaction occurs
• - condition worsens or does not improve within 7 days
• - symptoms clear up and return within a few days
• - redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• adults and children 2 years and older: apply externally to the affected area up to 3 to 4 times a day
• children under 2 years: ask a doctor

Other information

Store at room temperature 15°-30°C(59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients

CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerinGLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol sodium lauroamphoacetate sodium coco-sulfate xanthan gum Water PHENOXYETHANOL

PRINCIPAL DISPLAY PANEL - 5% 5 OZ Bottle Label

NDC: 82461-312-05

Medcore LLC

BENZOYL PEROXIDE 5% Acne wash

5 OZ

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

PRINCIPAL DISPLAY PANEL - 5% 8 OZ Bottle Label

NDC: 82461-312-08

Medcore LLC

BENZOYL PEROXIDE 5% Acne wash

8 OZ

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

PRINCIPAL DISPLAY PANEL - 10% 5 OZ Bottle Label

NDC: 82461-313-05

Medcore LLC

BENZOYL PEROXIDE 10% Acne wash

5 OZ

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

PRINCIPAL DISPLAY PANEL - 10% 8 OZ Bottle Label

NDC: 82461-313-08

Medcore LLC

BENZOYL PEROXIDE 10% Acne wash

8 OZ

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE 5% TOPICAL WASH 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82461-312
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
LAURETH-12 (UNII: OAH19558U1)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82461-312-05	148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/20/2025
2	NDC: 82461-312-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	10/20/2025

BENZOYL PEROXIDE 10% TOPICAL WASH 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82461-313
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
LAURETH-12 (UNII: OAH19558U1)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82461-313-05	148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/20/2025
2	NDC: 82461-313-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	10/20/2025

Labeler - Medcore LLC (069802634)