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

Purpose

Acne treatment

Description

 Benzoyl Peroxide 10% 


Medication Information

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.

Uses

For the treatment of acne                 

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



Inactive Ingredients

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

Description

 Benzoyl Peroxide 10% 

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



Active Ingredients

 Benzoyl Peroxide 10% 

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

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.

Uses

For the treatment of acne                 

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



Inactive Ingredients

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

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



Active Ingredients

 Benzoyl Peroxide 10% 

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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