Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ee049b13-d15a-495f-9c95-3f28c4161dae
Route
TOPICAL
Published
Effective Date 2011-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)
Inactive Ingredients
Water Carbomer Homopolymer Type C Glycerin Stearic Acid Sodium Lauryl Sulfate Isopropyl Alcohol Zinc Acetate Alcohol Aloe Cocamidopropyl Betaine Glycolic Acid Butylene Glycol Castor Oil Sodium Hydroxide Salicyl Alcohol Salicylic Acid Vitamin A Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-03-31
Description

Active Ingredient; Benzoyl Peroxide 2.5% (w/w)

Medication Information

Warnings and Precautions
•    Do not use in or near the eyes

•    Do not use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve
Indications and Usage
Indicated and use for the management of acne and removal of the acne spots, Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel.Children under 2 years of age, consult your doctor
Dosage and Administration
Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel. Children under 2 years of age, consult your doctor
Description

Active Ingredient; Benzoyl Peroxide 2.5% (w/w)

Section 50565-1

Keep out of reach of children, store in a cool dry place at room temperature.

Section 50570-1
•    Ask your doctor if you using other acne medications

•    Do not use if you are allergic to Benzoyl Peroxide

•    Do not use in or near the eyes

•    Do not use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Excessive dryness and peeling of skin occurs

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.

Section 51727-6
Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, ethyl alcohol, staeric acid, carbomer, sodium hydroxide, cocamidopropyl betain, sodium lauryl sulfate, castor oil,glycolic acid, salicylic acid, cocoa butter, vitamin E, vitamin A,  grape seeds oil.

Section 51945-4
carton.jpg
Section 55105-1
Use for the management of acne and pimples and acne spots removal.

Section 55106-9
Active Ingredient; Benzoyl Peroxide 2.5% (w/w)

Structured Label Content

Indications and Usage (34067-9)
Indicated and use for the management of acne and removal of the acne spots, Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel.Children under 2 years of age, consult your doctor
Dosage and Administration (34068-7)
Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel. Children under 2 years of age, consult your doctor
Warnings and Precautions (34071-1)
•    Do not use in or near the eyes

•    Do not use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve
Section 50565-1 (50565-1)

Keep out of reach of children, store in a cool dry place at room temperature.

Section 50570-1 (50570-1)
•    Ask your doctor if you using other acne medications

•    Do not use if you are allergic to Benzoyl Peroxide

•    Do not use in or near the eyes

•    Do not use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Excessive dryness and peeling of skin occurs

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.

Section 51727-6 (51727-6)
Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, ethyl alcohol, staeric acid, carbomer, sodium hydroxide, cocamidopropyl betain, sodium lauryl sulfate, castor oil,glycolic acid, salicylic acid, cocoa butter, vitamin E, vitamin A,  grape seeds oil.

Section 51945-4 (51945-4)
carton.jpg
Section 55105-1 (55105-1)
Use for the management of acne and pimples and acne spots removal.

Section 55106-9 (55106-9)
Active Ingredient; Benzoyl Peroxide 2.5% (w/w)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:14.009413 · Updated: 2026-03-14T22:52:37.403989