Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID db9b5de2-c07c-0b21-e053-2995a90ae9a9
Route
TOPICAL
Published
Effective Date 2022-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Scutellaria Baicalensis Root Annickia Chlorantha Bark Phenoxyethanol Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Saw Palmetto Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Niacinamide Doconexent Nigella Sativa Seed Oil Sodium Ascorbyl Phosphate Zinc Gluconate Tocopherol Ethylhexylglycerin Polysorbate 60 Water Dimethicone Butylene Glycol Sodium Phosphate, Monobasic Caprylyl Glycol Sodium Phosphate, Dibasic, Anhydrous Sodium Hydroxide Icosapent Glycerin Oleanolic Acid Hexylene Glycol Hydroxyethyl Cellulose, Unspecified Linoleic Acid Linolenic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01
Description

Active Ingredients Salicylic Acid 2 %

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

Description

Active Ingredients Salicylic Acid 2 %

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



If bothersome dryness or

peeling occurs,

Section 50567-7



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.

Section 50570-1

Do not use

If irritation occurs

Section 51727-6



Inactive Ingredients

Water (Aqua), Dimethicone,

Butylene Glycol, Dimethicone

Crosspolymer, Ammonium

Polyacryloyldimethyl Taurate,

Hydroxyethylcellulose,

Serenoa Serrulata (Saw

Palmetto) Fruit Extract,

Sodium Ascorbyl Phosphate,

Niacinamide, Linoleic Acid,

Linolenic Acid,

Docosahexaenoic Acid,

Eicosapentaenoic Acid,

Nigella Sativa (Black Cumin)

Seed Oil, Scutellaria

Baicalensis Root Extract, Zinc

Gluconate, Glycerin,

Tocopherol, Oleanolic Acid,

Enantia Chlorantha Bark

Extract, Caprylyl Glycol,

Ethylhexylglycerin, Hexylene

Glycol, Disodium Phosphate,

Phenoxyethanol, Polysorbate

60, Sodium Hydroxide,

Sodium Phosphate.

Section 51945-4

Section 55105-1



Purpose

Acne Treatment

Section 55106-9

Active Ingredients

Salicylic Acid 2 %

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

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)



If bothersome dryness or

peeling occurs,

Section 50567-7 (50567-7)



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.

Section 50570-1 (50570-1)

Do not use

If irritation occurs

Section 51727-6 (51727-6)



Inactive Ingredients

Water (Aqua), Dimethicone,

Butylene Glycol, Dimethicone

Crosspolymer, Ammonium

Polyacryloyldimethyl Taurate,

Hydroxyethylcellulose,

Serenoa Serrulata (Saw

Palmetto) Fruit Extract,

Sodium Ascorbyl Phosphate,

Niacinamide, Linoleic Acid,

Linolenic Acid,

Docosahexaenoic Acid,

Eicosapentaenoic Acid,

Nigella Sativa (Black Cumin)

Seed Oil, Scutellaria

Baicalensis Root Extract, Zinc

Gluconate, Glycerin,

Tocopherol, Oleanolic Acid,

Enantia Chlorantha Bark

Extract, Caprylyl Glycol,

Ethylhexylglycerin, Hexylene

Glycol, Disodium Phosphate,

Phenoxyethanol, Polysorbate

60, Sodium Hydroxide,

Sodium Phosphate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredients

Salicylic Acid 2 %

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: 2026-02-15T12:04:41.304326 · Updated: 2026-03-14T23:05:35.877028