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

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

■ 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.

Inactive Ingredients

WATER, SODIUM C14-16 OLEFIN SULFONATE, CARBOMER

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 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

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

■ 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.

Inactive Ingredients

WATER, SODIUM C14-16 OLEFIN SULFONATE, CARBOMER

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 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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