FDA.reportPublic FDA data

Cetaphil Gentle Clear BPO Acne Cleanser

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:00

Label at a glance#

ProductCetaphil Gentle Clear BPO Acne Cleanser
Active ingredientBenzoyl Peroxide
Label structure10 sections

Indications and uses

For the treatment of acne                 

Dosage and administration

■ 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 doc...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

 Benzoyl Peroxide 2.6% 

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne                 

Warnings

WARNINGS SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-866-735-4137

OTC - QUESTIONS SECTION

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

Principle Display Panel - 4.2 FL OZ tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BPO cleanser tube P55507-1
BPO cleanser tube P55507-1

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)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1655910benzoyl peroxide 2.6 % Medicated Liquid SoapPSN3
1655910benzoyl peroxide 26 MG/ML Medicated Liquid SoapSCD3
1655910benzoyl peroxide 2.6 % Medicated Liquid SoapSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4125-00Cetaphil Gentle Clear BPO Acne Cleanser124 mL in 1 TUBECREAM1243
0299-4125-05Cetaphil Gentle Clear BPO Acne Cleanser12 mL in 1 TUBECREAM123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4125CETAPHIL GENTLE CLEAR BPO ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [GALDERMA LABORATORIES, L.P.]3Current NDC, Legacy NDC, 2 package rows20231201_6397f20f-d69f-47e4-a123-4cc7e1abfcad.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-41250299-4125-00, 0299-4125-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
Water059QF0KO0RIACT
Magnesium Aluminum Silicate6M3P64V0NCIACT
GlycerinPDC6A3C0OXIACT
Sodium C14-16 Olefin SulfonateO9W3D3YF5UIACT
Polyethylene Glycol 3350G2M7P15E5PIACT
Laureth-2D4D38LT1L5IACT
PhenoxyethanolHIE492ZZ3TIACT
Xanthan GumTTV12P4NEEIACT
Glycyrrhizinate DipotassiumCA2Y0FE3FXIACT
Poloxamer 1241S66E28KXAIACT
Zinc GluconateU6WSN5SQ1ZIACT
Edetate Disodium7FLD91C86KIACT
Citric Acid Monohydrate2968PHW8QPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Gentle Clear BPO Acne CleanserBENZOYL PEROXIDEGalderma Laboratories, L.P.6397f20f-d69f-47e4-a123-4cc7e1abfcad2023-11-29WarningsExact identifier
ndc (package): 0299-4125-00
ndc (package): 0299-4125-05
ndc (product): 0299-4125
ndc11 (package): 00299412500
ndc11 (package): 00299412505
spl id: b20c8c1a-9311-4ad9-a713-fa3451dc6f7e
spl set id: 6397f20f-d69f-47e4-a123-4cc7e1abfcad

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.