Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID a7c9d509-6f3d-4963-a358-18562f0f2744
Route
TOPICAL
Published
Effective Date 2022-08-01
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 2022-01-01

Description

Salicylic Acid 2%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 2%

Use

For the management of acne

Section 42229-5

Distributed by: Galderma Laboratories, L.P.          

Fort Worth, TX 76177 USA

cetaphil.com

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

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  20 fl Oz Bottle



#1 Doctor Recommended

Sensitive Skincare Brand



Cetaphil®          

ACNE RELIEF

BODY WASH

Acne-Prone Skin

Maximum strength

OTC formula

to eliminate breakouts

24 hour dryness relief



Advanced Moisture Blend

2% Salicylic Acid

Acne Treatment


5 skin sensitivity signs

20 FL OZ (591 mL)

P55982-1


Structured Label Content

Use

For the management of acne

Section 42229-5 (42229-5)

Distributed by: Galderma Laboratories, L.P.          

Fort Worth, TX 76177 USA

cetaphil.com

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

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  20 fl Oz Bottle (PRINCIPAL DISPLAY PANEL - 20 FL OZ bottle)



#1 Doctor Recommended

Sensitive Skincare Brand



Cetaphil®          

ACNE RELIEF

BODY WASH

Acne-Prone Skin

Maximum strength

OTC formula

to eliminate breakouts

24 hour dryness relief



Advanced Moisture Blend

2% Salicylic Acid

Acne Treatment


5 skin sensitivity signs

20 FL OZ (591 mL)

P55982-1


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)