SPL v1
SPL
SPL Set ID 06e07266-6483-e7ef-e063-6294a90a9395
Route
TOPICAL
Published
Effective Date 2023-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (2.5 g)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Ethylhexylglycerin Chlorphenesin Water Laureth-4 Hypromelloses Sodium Hydroxide Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-04
Description

Benzoyl Peroxide 2.5%

Purpose

Acne Medication

Medication Information

Purpose

Acne Medication

Description

Benzoyl Peroxide 2.5%

Use

For the treatment of acne

Label

Warnings

For external use only

Directions
  • 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 directed by a doctor.
  • if some 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 2.5%

Do Not Use If You

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information

Store at 20ºC-25ºC (68ºF-77ºF)

Inactive Ingredients

Water

Laureth-4

Carbomer

Ethylhexylglycerin

Hydroxypropyl Methylcellulose

Chlorphenesin

Sodium Hydroxide

Disodium EDTA

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.

Keep Out of Reah of Children

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

Stop Use and Ask A Doctor If

irritation becomes severs.

Structured Label Content

Use

For the treatment of acne

Label (label)

Purpose

Acne Medication

Warnings

For external use only

Directions
  • 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 directed by a doctor.
  • if some 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 2.5%

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

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information (Other information)

Store at 20ºC-25ºC (68ºF-77ºF)

Inactive Ingredients (Inactive ingredients)

Water

Laureth-4

Carbomer

Ethylhexylglycerin

Hydroxypropyl Methylcellulose

Chlorphenesin

Sodium Hydroxide

Disodium EDTA

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.

Keep Out of Reah of Children (Keep out of reah of children)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation becomes severs.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:20.781608 · Updated: 2026-03-14T23:01:21.342577