Cetaphil Gentle Clear Bpo Acne Cleanser Cream
FDA Label NDC 0299-4125

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galderma Laboratories, L.p. for the product Cetaphil Gentle Clear Bpo Acne Cleanser (NDC 0299-4125). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

 Benzoyl Peroxide 2.6% 

Purpose

Acne treatment

Uses

For the treatment of acne                 

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

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.

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

Otc - Questions

Distributed by:

Galderma Laboratories, L.P.

Fort Worth, TX 76177
USA

All trademarks are the property of their respective owners

Made in Canada

Cetaphil.com.
P55507-0


Principle Display Panel - 4.2 Fl Oz Tube

NEW

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®                 

GENTLE CLEAR

Complexion-Clearing
BPO Acne Cleanser
2.6 % Benzoyl Peroxide
Acne Treatment



Micronized BPO starts
clearing breakouts after first
use without being harsh on
sensitive skin

Zinc and Licorice Root
reduce excess oil and
soothe skin

5 skin sensitivity signs

4.2 FL OZ (124 mL)









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