CETAPHIL GENTLE CLEAR BPO ACNE CLEANSER- benzoyl peroxide cream

Cetaphil Gentle Clear BPO Acne Cleanser by

Drug Labeling and Warnings

Cetaphil Gentle Clear BPO Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Fruit of The Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

STORAGE AND HANDLING

Questions or comments?

1-866-735-4137

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)

INGREDIENTS AND APPEARANCE

CETAPHIL GENTLE CLEAR BPO ACNE CLEANSER 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	2.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Glycerin (UNII: PDC6A3C0OX)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Laureth-2 (UNII: D4D38LT1L5)
Phenoxyethanol (UNII: HIE492ZZ3T)
Xanthan Gum (UNII: TTV12P4NEE)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Poloxamer 124 (UNII: 1S66E28KXA)
Zinc Gluconate (UNII: U6WSN5SQ1Z)
Edetate Disodium (UNII: 7FLD91C86K)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4125-00	124 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2022
2	NDC: 0299-4125-05	12 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/01/2022

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of The Earth, Inc.		080086802	manufacture(0299-4125)