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

Purpose

Acne Treatment

Description

Salicylic Acid 2%


Medication Information

Warnings

For external use only

Purpose

Acne Treatment

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.

Inactive Ingredients

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

Description

Salicylic Acid 2%

Use

For the management of acne

Active Ingredient

Salicylic Acid 2%

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

Warnings

For external use only

Purpose

Acne Treatment

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.

Inactive Ingredients

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

Use

For the management of acne

Active Ingredient

Salicylic Acid 2%

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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