SPL v2
SPL
SPL Set ID 23bb150b-f04a-469c-b834-731840d081ba
Route
TOPICAL
Published
Effective Date 2013-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (2.5 g)
Inactive Ingredients
Water Glycerin Polyacrylamide (1500 Mw) C13-14 Isoparaffin Laureth-7 Arbutin Kojic Acid Ascorbic Acid Sodium Pyrrolidone Carboxylate Allantoin Panthenol Glyceryl Abietate Phenoxyethanol Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-06-26
Description

ACTIVE INGREDIENT BENZOYL PEROXIDE 2.5%

Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

USE FOR THE TREATMENT OF ACNE

Dosage and Administration

DIRECTIONS

  • USE TWICE DAILY AM AND PM.
  • AFTER CLEANSING, APPLY TO ENTIRE FACE AVOIDING THE EYE AREA.
  • DO NOT RINSE.
  • ALLOW TO DRY.
  • IF GOING OUTSIDE, USE A SUNSCREEN. IF EXCESSIVE DRYNESS OR BOTHERSOME PEELING OCCURS, REDUCE APPLICATION USE.
Description

ACTIVE INGREDIENT BENZOYL PEROXIDE 2.5%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

Section 50567-7

WHEN USING THIS PRODUCT

  • AVOID CONTACT WTH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.
  • KEEP AWAY FROM LIPS AND MOUTH.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
Section 50568-5

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPCAL ACNE MEDICATONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASETHE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONEMEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Section 50570-1

DO NOT USE THIS MEDICATION IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE.

Section 51727-6

INACTIVE NGREDIENTS

WATER, GLYCERIN, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, ARBUTIN, KOJIC ACID, L-ASCORBIC ACID, SODIUM PCA, ALLANTOIN, PANTHENOL, HYDROGENATED METHYL ABIETATE, PHENOXYETHANOL, FRAGRANCE, METHYLISOTHIAZOLINONE

Section 51945-4

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

BENZOYL PEROXIDE 2.5%

Section 60561-8

OTHER INFORMATION

  • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS.
  • STORE AT ROOM TEMPERATURE.
  • AVOID STORING AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

Structured Label Content

Indications and Usage (34067-9)

USE FOR THE TREATMENT OF ACNE

Dosage and Administration (34068-7)

DIRECTIONS

  • USE TWICE DAILY AM AND PM.
  • AFTER CLEANSING, APPLY TO ENTIRE FACE AVOIDING THE EYE AREA.
  • DO NOT RINSE.
  • ALLOW TO DRY.
  • IF GOING OUTSIDE, USE A SUNSCREEN. IF EXCESSIVE DRYNESS OR BOTHERSOME PEELING OCCURS, REDUCE APPLICATION USE.
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 RIGHT AWAY.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT

  • AVOID CONTACT WTH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.
  • KEEP AWAY FROM LIPS AND MOUTH.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
Section 50568-5 (50568-5)

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPCAL ACNE MEDICATONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASETHE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONEMEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Section 50570-1 (50570-1)

DO NOT USE THIS MEDICATION IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE.

Section 51727-6 (51727-6)

INACTIVE NGREDIENTS

WATER, GLYCERIN, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, ARBUTIN, KOJIC ACID, L-ASCORBIC ACID, SODIUM PCA, ALLANTOIN, PANTHENOL, HYDROGENATED METHYL ABIETATE, PHENOXYETHANOL, FRAGRANCE, METHYLISOTHIAZOLINONE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

BENZOYL PEROXIDE 2.5%

Section 60561-8 (60561-8)

OTHER INFORMATION

  • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS.
  • STORE AT ROOM TEMPERATURE.
  • AVOID STORING AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:39.268137 · Updated: 2026-03-14T22:53:30.775793