Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 6397f20f-d69f-47e4-a123-4cc7e1abfcad
Route
TOPICAL
Published
Effective Date 2023-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (2.6 g)
Inactive Ingredients
Water Magnesium Aluminum Silicate Glycerin Sodium C14-16 Olefin Sulfonate Polyethylene Glycol 3350 Laureth-2 Phenoxyethanol Xanthan Gum Glycyrrhizinate Dipotassium Poloxamer 124 Zinc Gluconate Edetate Disodium Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

 Benzoyl Peroxide 2.6% 

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

 Benzoyl Peroxide 2.6% 

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

cetaphil.com.

P55507-1



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

■ Gently massage a dime-size amount onto dampened skin for 20 – 30 seconds, avoiding the eye area. Rinse thoroughly and pat dry. Can be used twice daily 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 2.6% 

Inactive Ingredients

WATER, MAGNESIUM ALUMINUM SILICATE, GLYCERIN, SODIUM C14-16 OLEFIN SULFONATE, PEG-75,PEG/PPG-120/10 TRIMETHYLOLPROPANE TRIOLEATE, LAURETH-2, PHENOXYETHANOL, XANTHAN GUM, DIPOTASSIUM GLYCYRRHIZATE, POLOXAMER 124, ZINC GLUCONATE, DISODIUM EDTA, CITRIC ACID

Questions Or Comments?

1-866-735-4137

Principle Display Panel 4.2 Fl Oz Tube

NEW LOOK



Cetaphil®                 

ACNE



GENTLE CLEAR

Complexion

Clearing Acne

Cleanser



2.6 % Benzoyl Peroxide

          Acne Treatment







Immediately targets

acne causing bacteria

to clear breakouts





Benzoyl Peroxide, Zinc &

Licorice Root



Dermatologist Recommended

Sensitive Skin 



4.2 FL OZ (124 mL)


















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

cetaphil.com.

P55507-1



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

■ Gently massage a dime-size amount onto dampened skin for 20 – 30 seconds, avoiding the eye area. Rinse thoroughly and pat dry. Can be used twice daily 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 2.6% 

Inactive Ingredients

WATER, MAGNESIUM ALUMINUM SILICATE, GLYCERIN, SODIUM C14-16 OLEFIN SULFONATE, PEG-75,PEG/PPG-120/10 TRIMETHYLOLPROPANE TRIOLEATE, LAURETH-2, PHENOXYETHANOL, XANTHAN GUM, DIPOTASSIUM GLYCYRRHIZATE, POLOXAMER 124, ZINC GLUCONATE, DISODIUM EDTA, CITRIC ACID

Questions Or Comments? (Questions or comments?)

1-866-735-4137

Principle Display Panel 4.2 Fl Oz Tube (Principle Display Panel - 4.2 FL OZ tube)

NEW LOOK



Cetaphil®                 

ACNE



GENTLE CLEAR

Complexion

Clearing Acne

Cleanser



2.6 % Benzoyl Peroxide

          Acne Treatment







Immediately targets

acne causing bacteria

to clear breakouts





Benzoyl Peroxide, Zinc &

Licorice Root



Dermatologist Recommended

Sensitive Skin 



4.2 FL OZ (124 mL)


















Advanced Ingredient Data


Raw Label Data

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