Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID dbb27841-7c9e-6d00-e053-2a95a90a6ab1
Route
TOPICAL
Published
Effective Date 2022-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)
Inactive Ingredients
Water Linolenic Acid Sodium Hydroxide Sorbitan Monostearate Phytate Sodium Hexylene Glycol Propanediol Glycerin Aloe Vera Leaf Doconexent Saw Palmetto Niacinamide Icosapent Dimethicone Silicon Dioxide Peg-40 Stearate Sodium Citrate Xanthan Gum Ethylhexylglycerin Linoleic Acid Zinc Gluconate Carbomer Homopolymer, Unspecified Type Docusate Sodium Scutellaria Baicalensis Root Tocopherol Caprylyl Glycol Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-02
Description

Active Ingredients Benzoyl Peroxide 2.5%

Medication Information

Warnings and Precautions



Warnings

For external use only

Indications and Usage



Uses

For the treatment of acne

Dosage and Administration



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 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.

Description

Active Ingredients Benzoyl Peroxide 2.5%

Section 50565-1



Keep out of reach of children

If product is swallowed,

get medical help or

contact a Poison Control

Center right away.

Section 50566-9



Stop use and ask a doctor

If irritation becomes severe

Section 50567-7



When using this product

• Avoid unnecessary sun

exposure & use a sunscreen

• Avoid contact with the

eyes, lips, and mouth

• Avoid contact with hair &

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.

Section 50570-1



Do not use

If you have very sensitive skin

Are sensitive to benzoyl

peroxide

Section 51727-6



Inactive Ingredients

Water (Aqua), Aloe Barbadensis

Leaf Juice, Glycerin, Serenoa

Serrulata (Saw Palmetto) Fruit

Extract, Niacinamide, Linoleic

Acid, Linolenic Acid, Docosahexaenoic

Acid, Eicosapentaenoic

Acid, Scutellaria Baicalensis

Root Extract, Zinc Gluconate,

Tocopherol, Dimethicone,

Silica, Carbomer, Caprylyl

Glycol, Diethylhexyl Sodium

Sulfosuccinate, Ethylhexylglycerin,

Hexylene Glycol, PEG-40

Stearate, Phenoxyethanol,

Propanediol, Sodium

Hydroxide, Sodium Citrate,

Sodium Phytate, Sorbitan

Stearate, Xanthan Gum.

Section 51945-4

Section 55105-1



Purpose

Acne Treatment

Section 55106-9



Active Ingredients

Benzoyl Peroxide 2.5%

Section 60561-8



Other Information

Store at 20°- 25°C (68° - 77°F)

Structured Label Content

Indications and Usage (34067-9)



Uses

For the treatment of acne

Dosage and Administration (34068-7)



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 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.

Warnings and Precautions (34071-1)



Warnings

For external use only

Section 50565-1 (50565-1)



Keep out of reach of children

If product is swallowed,

get medical help or

contact a Poison Control

Center right away.

Section 50566-9 (50566-9)



Stop use and ask a doctor

If irritation becomes severe

Section 50567-7 (50567-7)



When using this product

• Avoid unnecessary sun

exposure & use a sunscreen

• Avoid contact with the

eyes, lips, and mouth

• Avoid contact with hair &

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.

Section 50570-1 (50570-1)



Do not use

If you have very sensitive skin

Are sensitive to benzoyl

peroxide

Section 51727-6 (51727-6)



Inactive Ingredients

Water (Aqua), Aloe Barbadensis

Leaf Juice, Glycerin, Serenoa

Serrulata (Saw Palmetto) Fruit

Extract, Niacinamide, Linoleic

Acid, Linolenic Acid, Docosahexaenoic

Acid, Eicosapentaenoic

Acid, Scutellaria Baicalensis

Root Extract, Zinc Gluconate,

Tocopherol, Dimethicone,

Silica, Carbomer, Caprylyl

Glycol, Diethylhexyl Sodium

Sulfosuccinate, Ethylhexylglycerin,

Hexylene Glycol, PEG-40

Stearate, Phenoxyethanol,

Propanediol, Sodium

Hydroxide, Sodium Citrate,

Sodium Phytate, Sorbitan

Stearate, Xanthan Gum.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Purpose

Acne Treatment

Section 55106-9 (55106-9)



Active Ingredients

Benzoyl Peroxide 2.5%

Section 60561-8 (60561-8)



Other Information

Store at 20°- 25°C (68° - 77°F)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:41.305521 · Updated: 2026-03-14T23:05:35.877028