Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID cf49ed9b-8c1d-49f9-8c77-bb6a5abce9e4
Route
TOPICAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (40 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Cocamidopropyl Hydroxysultaine Sodium C14-16 Olefin Sulfonate Xanthan Gum Potassium Hydroxide Sodium Chloride Sodium Citrate Niacinamide Sodium Hyaluronate Capryloyl Salicylic Acid Propanediol Diethylhexyl Sodium Sulfosuccinate Carbomer Benzoic Acid Pentylene Glycol Sodium Hydroxide Glycolic Acid Tetrasodium Edta Trisodium Ethylenediamine Disuccinate Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Benzoyl peroxide 4.0%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 4.0%

Uses
  • for the treatment of acne
  • helps clear up blemishes and allows skin to heal
Section 51945-4

Warnings

For external use only

Directions

• apply a dime-size amount to damp skin

• gently massage, avoiding the eye area

• rinse well

• use cleanser on entire affected area, every morning and evening

• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

Active Ingredient

Benzoyl peroxide 4.0%

Do Not Use If You

have very sensitive skin

are sensitive to benzoyl peroxide

Inactive Ingredients

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, potassium hydroxide, sodium chloride, sodium citrate, niacinamide, sodium hyaluronate, capryloyl salicylic acid, propanediol, diethylhexyl sodium sulfosuccinate, carbomer, benzoic acid, pentylene glycol, sodium hydroxide, glycolic acid, tetrasodium EDTA, trisodium ethylenediamine disuccinate, citric acid

Questions Or Comments?

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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.
Stop Use and Ask A Doctor If

irritation becomes severe

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • for the treatment of acne
  • helps clear up blemishes and allows skin to heal
Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions

• apply a dime-size amount to damp skin

• gently massage, avoiding the eye area

• rinse well

• use cleanser on entire affected area, every morning and evening

• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

Active Ingredient (Active ingredient)

Benzoyl peroxide 4.0%

Do Not Use If You (Do not use if you)

have very sensitive skin

are sensitive to benzoyl peroxide

Inactive Ingredients (Inactive ingredients)

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, potassium hydroxide, sodium chloride, sodium citrate, niacinamide, sodium hyaluronate, capryloyl salicylic acid, propanediol, diethylhexyl sodium sulfosuccinate, carbomer, benzoic acid, pentylene glycol, sodium hydroxide, glycolic acid, tetrasodium EDTA, trisodium ethylenediamine disuccinate, citric acid

Questions Or Comments? (Questions or comments?)

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

When Using This Product (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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation becomes severe

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

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


Advanced Ingredient Data


Raw Label Data

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