Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3c4c2f52-0d37-4a3b-9a8d-2d54574b58d2
Route
TOPICAL
Published
Effective Date 2025-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Glycerin Kaolin Sodium Cocoyl Isethionate Glyceryl Stearate Se Cetyl Alcohol Niacinamide Carrageenan Ceramide Np Ceramide Ap Yeast .beta.-d-glucan Carbomer Triethyl Citrate Sodium Hydroxide Sodium Benzoate Sodium Lauroyl Lactylate Cholesterol Caprylyl Glycol Trisodium Ethylenediamine Disuccinate Lactic Acid Phytosphingosine Xanthan Gum Benzoic Acid Poliglusam

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Salicylic acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 2%

Uses

• for the treatment of acne

• clears acne blemishes and allows skin to heal

• helps prevent new acne blemishes from forming

Section 51945-4

Warnings

For external use only

Directions

For use as a cleanser:

• use twice daily

• massage onto skin with wet hands to transform clay

into foam

• avoid contact with eyes. If contact occurs, rinse

thoroughly with water

• rinse well

For use as a mask:

• apply even layer to clean, damp skin two times per

week

• leave on for ten minutes

• rinse off

For use as a spot treatment:

• clean the skin thoroughly before applying this product

• cover the entire affected area with 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

Active Ingredient

Salicylic acid 2%

Inactive Ingredients

water, glycerin, kaolin, sodium cocoyl isethionate,

glyceryl stearate SE, cetyl alcohol, niacinamide,

glycolipids, carrageenan, beta-glucan, ceramide NP,

ceramide AP, ceramide EOP, carbomer, triethyl citrate,

sodium hydroxide, sodium benzoate, sodium lauroyl

lactylate, cholesterol, caprylyl glycol, trisodium

ethylenediamine disuccinate, lactic acid, chitosan,

phytosphingosine, xanthan gum, benzoic acid

Questions Or Comments?

Toll-free number 1-888-768-2915

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.

Keep Out of Reach of Children.

If swallowed, get

medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

• for the treatment of acne

• clears acne blemishes and allows skin to heal

• helps prevent new acne blemishes from forming

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions

For use as a cleanser:

• use twice daily

• massage onto skin with wet hands to transform clay

into foam

• avoid contact with eyes. If contact occurs, rinse

thoroughly with water

• rinse well

For use as a mask:

• apply even layer to clean, damp skin two times per

week

• leave on for ten minutes

• rinse off

For use as a spot treatment:

• clean the skin thoroughly before applying this product

• cover the entire affected area with 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

Active Ingredient (Active ingredient)

Salicylic acid 2%

Inactive Ingredients (Inactive ingredients)

water, glycerin, kaolin, sodium cocoyl isethionate,

glyceryl stearate SE, cetyl alcohol, niacinamide,

glycolipids, carrageenan, beta-glucan, ceramide NP,

ceramide AP, ceramide EOP, carbomer, triethyl citrate,

sodium hydroxide, sodium benzoate, sodium lauroyl

lactylate, cholesterol, caprylyl glycol, trisodium

ethylenediamine disuccinate, lactic acid, chitosan,

phytosphingosine, xanthan gum, benzoic acid

Questions Or Comments? (Questions or comments?)

Toll-free number 1-888-768-2915

When Using This Product (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get

medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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