DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Benzoyl Peroxide (50 mg)

Inactive Ingredients

Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cetyl Alcohol Edetate Disodium Glycerin Glyceryl Stearate/peg-100 Stearate Laureth-12 Magnesium Aluminum Silicate Propylene Glycol Sodium Lauroamphoacetate Sodium Coco-sulfate Xanthan Gum Water Phenoxyethanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-20

Medication Information

Purpose

Acne medication

Description

BENZOYL PEROXIDE 5% or 10%

Uses

For the treatment of acne

Section 50570-1

-
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

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.

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

Drug Facts

Active Ingredient

BENZOYL PEROXIDE 5% or 10%

Other Information

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

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

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

Keep Out of the Reach of Children.

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

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

Structured Label Content

Uses

For the treatment of acne

Section 50570-1 (50570-1)

-
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

Purpose

Acne medication

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.

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

Drug Facts

Active Ingredient (Active ingredient)

BENZOYL PEROXIDE 5% or 10%

Other Information (Other information)

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

Instructions for Use (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

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

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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

Principal Display Panel 5% 5 Oz Bottle Label (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 (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 (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 (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

Advanced Ingredient Data

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"unii": "OAH19558U1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM ALUMINUM SILICATE", "unii": "6M3P64V0NC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAUROAMPHOACETATE", "unii": "SLK428451L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM COCO-SULFATE", "unii": "3599J29ANH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOYL PEROXIDE", "unii": "W9WZN9A0GM", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE/PEG-100 STEARATE", "unii": "RD25J5V947", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURETH-12", "unii": "OAH19558U1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM ALUMINUM SILICATE", "unii": "6M3P64V0NC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAUROAMPHOACETATE", "unii": "SLK428451L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM COCO-SULFATE", "unii": "3599J29ANH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOYL PEROXIDE", "unii": "W9WZN9A0GM", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the treatment of acne", "50570-1": "- 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", "Purpose": "Acne medication", "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.", "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", "Active ingredient": "BENZOYL PEROXIDE 5% or 10%", "Other information": "Store at room temperature 15°-30°C(59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.", "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", "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", "Keep out of the reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information