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

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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 olderapply externally to the affected area up to 3 to 4 times a day
children under 2 yearsask 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

Label-1

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

Label-1

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

Label-1

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

Label-1

BENZOYL PEROXIDE 5% TOPICAL WASH 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82461-312
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82461-312-05148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2025
2NDC:82461-312-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00610/20/2025
BENZOYL PEROXIDE 10% TOPICAL WASH 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82461-313
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82461-313-05148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2025
2NDC:82461-313-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00610/20/2025
Labeler - Medcore LLC (069802634)

Revised: 10/2025
Document Id: 14cd67f2-dc7d-484b-bd21-bcb09c7f779e
Set id: 14bf3034-2fe8-44b9-9e26-e804b6046837
Version: 1
Effective Time: 20251022
 
Medcore LLC