Cetaphil Gentle Clear Triple-Action Acne Serum

Manufacturer
Galderma Laboratories, L.P. | Fruit of The Earth, Inc.
Effective date
2023-11-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:35

Label at a glance#

ProductCetaphil Gentle Clear Triple-Action Acne Serum
Active ingredientSalicylic Acid
Label structure10 sections

Indications and uses

For the management of acne                 

Dosage and administration

• Sensitivity Test for New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below. • clean the skin thoroughly before applying this product. • cover the entire affected area with a thin layer one to three times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase t...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5% 

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

For the management of acne                 

Warnings

WARNINGS SECTION

For external use only.

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 treatment at a time. ■ avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

•Sensitivity Test for New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below. • clean the skin thoroughly before applying this product. • cover the entire affected area with a thin layer one to three times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, COCO-CAPRYLATE/CAPRATE, GLUCONOLACTONE, PROPANEDIOL, SODIUM HYDROXIDE, SUCCINIC ACID, PANTHENOL, NIACINAMIDE, LYSOLECITHIN, SCLEROTIUM GUM, ZINC GLUCONATE, PULLULAN, XANTHAN GUM, PANTOLACTONE, CITRIC ACID, SILICA

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.

cetaphil.com.
P56577-1

Principle Display Panel - 1 FL OZ Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

triple action serum carton
triple action serum carton

NEW LOOK

Cetaphil®                 

ACNE
GENTLE CLEAR

Triple-Action
Acne Serum

0.5% Salicylic Acid Acne Treatment



Hydrates, soothes and
resurfaces to visibly improve
breakouts in 3 days

Salicylic Acid,
Niacinamide
& Prebiotic 

Dermatologist Recommended
Sensitive Skin

1 FL OZ (30 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN2
199308salicylic acid 5 MG/ML Topical SolutionSCD2
199308salicylic acid 0.5 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4135-00Cetaphil Gentle Clear Triple-Action Acne Serum30 mL in 1 TUBESOLUTION302
0299-4135-00Cetaphil Gentle Clear Triple-Action Acne Serum1 in 1 CARTONSOLUTION12
0299-4135-05Cetaphil Gentle Clear Triple-Action Acne Serum5 mL in 1 TUBESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4135CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM (SALICYLIC ACID) SOLUTION [GALDERMA LABORATORIES, L.P.]2Current NDC, Legacy NDC, 3 package rows20231122_3e6eb59f-c523-460e-87ed-750b4a8cacac.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-41350299-4135-00, 0299-4135-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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 Triple-Action Acne SerumSALICYLIC ACIDGalderma Laboratories, L.P.3e6eb59f-c523-460e-87ed-750b4a8cacac2023-11-16WarningsExact identifier
ndc (package): 0299-4135-05
ndc (package): 0299-4135-00
ndc (product): 0299-4135
ndc11 (package): 00299413500
ndc11 (package): 00299413505
spl id: 6ef04144-8863-42f8-8f29-b93a0a5ec996
spl set id: 3e6eb59f-c523-460e-87ed-750b4a8cacac

Reported adverse events (FAERS/openFDA)#

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