SPL v2
SPL
SPL Set ID 72f6e761-d0c4-1a84-e053-2991aa0aad7c
Route
TOPICAL
Published
Effective Date 2018-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Aminomethylpropanol Propylene Glycol 1-(2-methylbutyrate) Potassium Sorbate Laureth-7 C13-14 Isoparaffin Glycerin Phenoxyethanol Ethylhexylglycerin Magnesium Disodium Edta

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-26
Description

Benzoyl Peroxide 5%

Medication Information

Warnings and Precautions

WARNINGS: For External Use Only

Indications and Usage

treats acne and helps prevent new acne blemishes from forming

kills acne bacteria

Dosage and Administration

Directions:

  • Cleanse skin thoroughy before applying
  • Cover entire affected area with thin layer 1 to 3 times daily
  • If excessive dryness or irritation occurs, reduce application to once a day or every other day
  • If going outside, use a sunscreen
Description

Benzoyl Peroxide 5%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Section 50567-7

When using this product:

  • avoid sun exposure and use sunscreen
  • using other acne medications at the same time may cause excessive dryness or irritation of the skin
  • may bleach hair and fabrics
  • do not use in or near eyes, lips and mouth
Section 50569-3

Consult a doctor if excessive irritation occurs

Section 50570-1

Do not use

  • If you have very sensitive skin
  • If you are sensitive to benzoyl peroxide
Section 51727-6

Water, Carbomer, Glycerin, Propylene Glycol, Ethoxydigiycol, Laureth-7, Polyacrylamide C13-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol

Section 51945-4

Section 55105-1

Acne Medication

Section 55106-9

Benzoyl Peroxide 5%

Section 60561-8

Other Information

  • Store at room temperature
  • Keep tightly closed

Structured Label Content

Indications and Usage (34067-9)

treats acne and helps prevent new acne blemishes from forming

kills acne bacteria

Dosage and Administration (34068-7)

Directions:

  • Cleanse skin thoroughy before applying
  • Cover entire affected area with thin layer 1 to 3 times daily
  • If excessive dryness or irritation occurs, reduce application to once a day or every other day
  • If going outside, use a sunscreen
Warnings and Precautions (34071-1)

WARNINGS: For External Use Only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Section 50567-7 (50567-7)

When using this product:

  • avoid sun exposure and use sunscreen
  • using other acne medications at the same time may cause excessive dryness or irritation of the skin
  • may bleach hair and fabrics
  • do not use in or near eyes, lips and mouth
Section 50569-3 (50569-3)

Consult a doctor if excessive irritation occurs

Section 50570-1 (50570-1)

Do not use

  • If you have very sensitive skin
  • If you are sensitive to benzoyl peroxide
Section 51727-6 (51727-6)

Water, Carbomer, Glycerin, Propylene Glycol, Ethoxydigiycol, Laureth-7, Polyacrylamide C13-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne Medication

Section 55106-9 (55106-9)

Benzoyl Peroxide 5%

Section 60561-8 (60561-8)

Other Information

  • Store at room temperature
  • Keep tightly closed

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:02.595549 · Updated: 2026-03-14T22:55:53.187482