Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID ce4d1074-5f74-4ad7-9535-2737f5fff24f
Route
TOPICAL
Published
Effective Date 2022-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Alcohol Glycolic Acid Hamamelis Virginiana Top Water Polysorbate 20 Ammonia Edetate Disodium Anhydrous

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

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. • 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.

Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

Water, Alcohol Denat., Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate 20, Ammonium Hydroxide, Disodium EDTA

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 6 Oz Bottle



NEW



DIFFERIN®



ACNE

TREATMENT

     

ACNE - CLEARING

BODY SPRAY

2% Salicylic Acid



Maximum strength OTC ingredient

helps eliminate acne bumps, pimples,

and blackheads

Contains Witch Hazel to soothe the skin



360° Continuous Non-Aerosol Spray





NET WT 6 OZ (170 g)

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

P56873-0


Structured Label Content

Use

For the management of acne

Purpose

Acne Treatment

Warnings

For external use only

Directions

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. • 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.

Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

Water, Alcohol Denat., Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate 20, Ammonium Hydroxide, Disodium EDTA

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 6 Oz Bottle (PRINCIPAL DISPLAY PANEL - 6 OZ bottle)



NEW



DIFFERIN®



ACNE

TREATMENT

     

ACNE - CLEARING

BODY SPRAY

2% Salicylic Acid



Maximum strength OTC ingredient

helps eliminate acne bumps, pimples,

and blackheads

Contains Witch Hazel to soothe the skin



360° Continuous Non-Aerosol Spray





NET WT 6 OZ (170 g)

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

P56873-0


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