Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 8ecb680f-f883-4e5e-a0ca-e839ad2b02cf
Route
TOPICAL
Published
Effective Date 2023-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-11

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

■ Wet face and gently massage all over face for about 20 – 30 seconds, avoiding the eye area. Rinse thoroughly and pat dry. ■ 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

WATER, SODIUM C14-16 OLEFIN SULFONATE, CARBOMER

Questions Or Comments?

1-866-735-4137

Principle Display Panel 5 Fl Oz Carton

10% Benzoyl Peroxide 



DIFFERIN®                 

CLEANSE

Maximum Strength

Acne Foaming Cleanser

10% Benzoyl Peroxide

Acne Treatment

Maximum Strength

OTC Ingredient 

Stops Acne-Causing

Bacteria and Helps

Prevent Future Breakouts



For Use on the

Face & Body



5 FL OZ (148 mL)



P57264-1






















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

■ Wet face and gently massage all over face for about 20 – 30 seconds, avoiding the eye area. Rinse thoroughly and pat dry. ■ 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

WATER, SODIUM C14-16 OLEFIN SULFONATE, CARBOMER

Questions Or Comments? (Questions or comments?)

1-866-735-4137

Principle Display Panel 5 Fl Oz Carton (Principle Display Panel - 5 FL OZ carton)

10% Benzoyl Peroxide 



DIFFERIN®                 

CLEANSE

Maximum Strength

Acne Foaming Cleanser

10% Benzoyl Peroxide

Acne Treatment

Maximum Strength

OTC Ingredient 

Stops Acne-Causing

Bacteria and Helps

Prevent Future Breakouts



For Use on the

Face & Body



5 FL OZ (148 mL)



P57264-1






















Advanced Ingredient Data


Raw Label Data

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