Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 05468eab-f239-42cb-9106-055a105f0fa5
Route
TOPICAL
Published
Effective Date 2024-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Carbomer Homopolymer, Unspecified Type Docusate Sodium Edetate Disodium Anhydrous Glycerin Poloxamer 182 Propylene Glycol Silicon Dioxide Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-06

Description

 Benzoyl Peroxide 10% 

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

 Benzoyl Peroxide 10% 

Uses

For the treatment of acne                 

Section 50565-1

Keep out of reach of children.

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

Section 53413-1

Distributed by:

Galderma Laboratories, L.P.

Dallas, TX 75201

USA

All trademarks are the property of their respective owners

Made in Canada

www.differin.com



Warnings

For external use only.

Do not use if you

■ have very sensitive skin

■ are sensitive to benzoyl peroxide

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.

■ avoid unnecessary sun exposure and use a sunscreen

■ avoid contact with the eyes, lips, and mouth

■ avoid contact with hair and dyed fabrics, which may be bleached by this product

■ skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

■ irritation becomes severe.

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 ■ if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor



Active Ingredients

 Benzoyl Peroxide 10% 

Inactive Ingredients

Acrylates Copolymer, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Disodium EDTA, Glycerin, Poloxamer 182, Propylene Glycol, Silica, Sodium Hydroxide, Water

Questions Or Comments?

1-866-735-4137

Principle Display Panel    1 Oz (28 G) Carton

NEW



DIFFERIN®                 

Acne



Spot

Treatment

10%

BENZOYL

PEROXIDE

Acne Treatment

MAXIMUM STRENGTH

Reduces Acne Size & Redness

VISIBLE RESULTS AFTER 1 DAY





NET WT 1 OZ (28 g)

P57672-0


















Structured Label Content

Uses

For the treatment of acne                 

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 53413-1 (53413-1)

Distributed by:

Galderma Laboratories, L.P.

Dallas, TX 75201

USA

All trademarks are the property of their respective owners

Made in Canada

www.differin.com



Purpose

Acne treatment

Warnings

For external use only.

Do not use if you

■ have very sensitive skin

■ are sensitive to benzoyl peroxide

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.

■ avoid unnecessary sun exposure and use a sunscreen

■ avoid contact with the eyes, lips, and mouth

■ avoid contact with hair and dyed fabrics, which may be bleached by this product

■ skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

■ irritation becomes severe.

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 ■ if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor



Active Ingredients

 Benzoyl Peroxide 10% 

Inactive Ingredients

Acrylates Copolymer, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Disodium EDTA, Glycerin, Poloxamer 182, Propylene Glycol, Silica, Sodium Hydroxide, Water

Questions Or Comments? (Questions or comments?)

1-866-735-4137

Principle Display Panel    1 Oz (28 G) Carton (Principle Display Panel -   1 OZ (28 g) carton)

NEW



DIFFERIN®                 

Acne



Spot

Treatment

10%

BENZOYL

PEROXIDE

Acne Treatment

MAXIMUM STRENGTH

Reduces Acne Size & Redness

VISIBLE RESULTS AFTER 1 DAY





NET WT 1 OZ (28 g)

P57672-0


















Advanced Ingredient Data


Raw Label Data

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