Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b280351f-02d4-4456-85b5-905e83596848
Route
TOPICAL
Published
Effective Date 2022-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

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 of peeling occurs, reduce application use.

Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

Water, Cocamidopropyl Betaine, Sodium Lauroyl Isethionate, Hydroxypropyl Starch Phosphate, Lauric Acid, Sodium Chloride, Sodium Lauroyl Glycinate, Glycine Soja (Soybean) Oil, Hydrogenated Soybean Oil, Glycerin, Phenoxyethanol, Palmitic Acid, Stearic Acid, Benzyl Alcohol, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Sodium Benzoate, Butyrospermum Parkii (Shea) Butter, Glycolic Acid, Tetrasodium EDTA, Tanacetum Annuum Flower Oil

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.

Questions Or Comments? 1 866 735 4137

Distributed by: Galderma Laboratories, L.P.,

Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

www.differin.com

P56660-0

Principal Display Panel 10 Fl Oz Tube



NEW



DIFFERIN®



CLEANSE         

ACNE - CLEARING

BODY WASH

2% Salicylic Acid

Acne Treatment

Contains a blend of Salicylic Acid

to unclog pores and Blue Tansy

Extract to soothe

For use on the chest, back and

shoulders



Dryness relief for up to 24 hours





10 FL OZ (295 mL)


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 of peeling occurs, reduce application use.

Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

Water, Cocamidopropyl Betaine, Sodium Lauroyl Isethionate, Hydroxypropyl Starch Phosphate, Lauric Acid, Sodium Chloride, Sodium Lauroyl Glycinate, Glycine Soja (Soybean) Oil, Hydrogenated Soybean Oil, Glycerin, Phenoxyethanol, Palmitic Acid, Stearic Acid, Benzyl Alcohol, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Sodium Benzoate, Butyrospermum Parkii (Shea) Butter, Glycolic Acid, Tetrasodium EDTA, Tanacetum Annuum Flower Oil

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.

Questions Or Comments? 1 866 735 4137 (Questions or comments? 1-866-735-4137)

Distributed by: Galderma Laboratories, L.P.,

Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

www.differin.com

P56660-0

Principal Display Panel 10 Fl Oz Tube (PRINCIPAL DISPLAY PANEL - 10 FL OZ tube)



NEW



DIFFERIN®



CLEANSE         

ACNE - CLEARING

BODY WASH

2% Salicylic Acid

Acne Treatment

Contains a blend of Salicylic Acid

to unclog pores and Blue Tansy

Extract to soothe

For use on the chest, back and

shoulders



Dryness relief for up to 24 hours





10 FL OZ (295 mL)


Advanced Ingredient Data


Raw Label Data

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