FDA.reportPublic FDA data

Cetaphil Gentle Clear Pore Clearing Acne Cleanser

Manufacturer
Galderma Laboratories, L.P. | Fruit of The Earth, Inc
Effective date
2024-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:08

Label at a glance#

ProductCetaphil Gentle Clear Pore Clearing Acne Cleanser
Active ingredientSalicylic Acid
Label structure11 sections

Dosage and administration

Apply to dampened skin and gently massage. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the management of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

• 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• irritation becomes severe.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to dampened skin and gently massage. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BENZYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCAMIDOPROPYL BETAINE, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROGENATED SOYBEAN OIL, HYDROXYPROPYL STARCH PHOSPHATE, LACTIC ACID, LAURIC ACID, PALMITIC ACID, PHENOXYETHANOL, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYDROXIDE, SODIUM LAUROYL GLYCINATE, SODIUM LAUROYL ISETHIONATE, STEARIC ACID, TETRASODIUM EDTA, WATER

Questions or comments? 1-866-735-4137

SPL UNCLASSIFIED SECTION

Distributed by:
Galderma Laboratories, L.P.          
Dallas, TX 75201 USA

All trademarks are the property
of their respective owners.
cetaphil.com

PRINCIPAL DISPLAY PANEL - 8 FL OZ bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Cetaphil®          

ACNE 
Gentle Clear
Pore Clearing Acne Cleanser

2% Salicylic Acid Acne Treatment

Gently clears breakouts and provides
24-hour dryness relief

Salicylic Acid
Advanced Moisture Blend

Dermatologist Recommended
Sencitive Skin

8 FL OZ (237 mL)
P57613-0

P57613-0 new front and back
P57613-0 new front and back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN1
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1
562600salicylic acid 2 % Facial Cleanser TonerSY1
562600salicylic acid 2 % Facial ScrubSY1
562600salicylic acid 2 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4143-00Cetaphil Gentle Clear Pore Clearing Acne Cleanser237 mL in 1 BOTTLEGEL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4143CETAPHIL GENTLE CLEAR PORE CLEARING ACNE CLEANSER (SALICYLIC ACID) GEL [GALDERMA LABORATORIES, L.P.]1Current NDC, 1 package rows20240531_fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-41430299-4143-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Benzyl AlcoholLKG8494WBHIACT
Shea ButterK49155WL9YIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
GlycerinPDC6A3C0OXIACT
Soybean Oil241ATL177AIACT
Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide)B16G315W7AIACT
Hydrogenated Soybean OilA2M91M918CIACT
Lactic Acid, Unspecified Form33X04XA5ATIACT
Lauric Acid1160N9NU9UIACT
Palmitic Acid2V16EO95H1IACT
PhenoxyethanolHIE492ZZ3TIACT
Sodium BenzoateOJ245FE5EUIACT
Sodium Chloride451W47IQ8XIACT
Sodium Hydroxide55X04QC32IIACT
Sodium Lauroyl GlycinateL54QIO80PNIACT
Sodium Lauroyl IsethionateM590021Z02IACT
Stearic Acid4ELV7Z65APIACT
Edetate SodiumMP1J8420LUIACT
Water059QF0KO0RIACT

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 Pore Clearing Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe2024-05-09WarningsExact identifier
ndc (package): 0299-4143-00
ndc (product): 0299-4143
ndc11 (package): 00299414300
spl id: 278f3ece-c353-4fdb-be9b-48d5575ef9c1
spl set id: fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe

Reported adverse events (FAERS/openFDA)#

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