Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe
Route
TOPICAL
Published
Effective Date 2024-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Benzyl Alcohol Shea Butter Cocamidopropyl Betaine Glycerin Soybean Oil Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Hydrogenated Soybean Oil Lactic Acid, Unspecified Form Lauric Acid Palmitic Acid Phenoxyethanol Sodium Benzoate Sodium Chloride Sodium Hydroxide Sodium Lauroyl Glycinate Sodium Lauroyl Isethionate Stearic Acid Edetate Sodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-31

Description

Salicylic Acid 2%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 2%

Use

For the management of acne

Warnings

For external use only

Directions

Apply to dampened skin and gently massage. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application use.

Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

BENZYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCAMIDOPROPYL BETAINE, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROGENATED SOYBEAN OIL, HYDROXYPROPYL STARCH PHOSPHATE, LACTIC ACID, LAURIC ACID, PALMITIC ACID, PHENOXYETHANOL, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYDROXIDE, SODIUM LAUROYL GLYCINATE, SODIUM LAUROYL ISETHIONATE, STEARIC ACID, TETRASODIUM EDTA, WATER

Questions Or Comments?

Distributed by:

Galderma Laboratories, L.P.          

Dallas, TX 75201 USA



All trademarks are the property

of their respective owners.

cetaphil.com

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.

Stop Use and Ask A Doctor If

• irritation becomes severe.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 8 Fl Oz Bottle



NEW



Cetaphil®          

ACNE 

Gentle Clear

Pore Clearing Acne Cleanser

2% Salicylic Acid Acne Treatment

Gently clears breakouts and provides

24-hour dryness relief

Salicylic Acid

Advanced Moisture Blend

Dermatologist Recommended

Sencitive Skin



8 FL OZ (237 mL)

P57613-0


Structured Label Content

Use

For the management of acne

Purpose

Acne Treatment

Warnings

For external use only

Directions

Apply to dampened skin and gently massage. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application use.

Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

BENZYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCAMIDOPROPYL BETAINE, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROGENATED SOYBEAN OIL, HYDROXYPROPYL STARCH PHOSPHATE, LACTIC ACID, LAURIC ACID, PALMITIC ACID, PHENOXYETHANOL, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYDROXIDE, SODIUM LAUROYL GLYCINATE, SODIUM LAUROYL ISETHIONATE, STEARIC ACID, TETRASODIUM EDTA, WATER

Questions Or Comments? (Questions or comments?)

Distributed by:

Galderma Laboratories, L.P.          

Dallas, TX 75201 USA



All trademarks are the property

of their respective owners.

cetaphil.com

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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• irritation becomes severe.

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.

Principal Display Panel 8 Fl Oz Bottle (PRINCIPAL DISPLAY PANEL - 8 FL OZ bottle)



NEW



Cetaphil®          

ACNE 

Gentle Clear

Pore Clearing Acne Cleanser

2% Salicylic Acid Acne Treatment

Gently clears breakouts and provides

24-hour dryness relief

Salicylic Acid

Advanced Moisture Blend

Dermatologist Recommended

Sencitive Skin



8 FL OZ (237 mL)

P57613-0


Advanced Ingredient Data


Raw Label Data

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