FDA.reportPublic FDA data

Cetaphil Cracked Skin Repair

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2023-11-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:16

Label at a glance#

ProductCetaphil Cracked Skin Repair
Active ingredientDimethicone
Label structure7 sections

Indications and uses

● helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ● temporary protects minor:    ● cuts ● scrapes ● burns ● helps prevent and protect from the drying effects of wind and cold weather  

Dosage and administration

● Apply generously to affected area as needed

Label contents#

Full prescribing information#

Active ingredients......Purpose

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%......Skin protectant

Uses

INDICATIONS & USAGE SECTION

● helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
● temporary protects minor:
   ● cuts ● scrapes ● burns
● helps prevent and protect from the drying effects of wind and cold weather  

Warnings

WARNINGS SECTION

For external use only.

When using this product ● do not get into eyes.            

Stop use and ask a doctor if ● condition worsens ● symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on  ● deep or puncture wounds ● animal bites ● serious burns

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

Directions

DOSAGE & ADMINISTRATION SECTION

● Apply generously to affected area as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED CASTOR OIL, LACTIC ACID, METHOXY PEG-22/DODECYL GLYCOL COPOLYMER, METHYLPARABEN, MINERAL OIL, OZOKERITE, PEG-2 HYDROGENATED CASTOR OIL, PEG-7 HYDROGENATED CASTOR OIL, PROPYLPARABEN, SODIUM LACTATE, SORBITAN ISOSTEARATE, UREA, WATER

Questions or comments?

OTC - QUESTIONS SECTION

1-866-735-4137

Distributed By:
Galderma Laboratories, L.P.
Dallas, TX 75201

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

PRINCIPLE DISPLAY PANEL - 16 FL OZ pump label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermatologist Recommended
For Sensitive Skin

Cetaphil®

Cracked Skin Repair Lotion
Skin Protectant Dimethicone

Rough, Cracked Sensitive Skin

Daily use lotion is designed to hydrate
and restore rough skin and prevent
cracked skin from coming back.

Urea

5 skin sensitivity signs

16 FL OZ (473 mL)

P56383-1

Cet Cracked skin lotion P56383-1
Cet Cracked skin lotion P56383-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198605dimethicone 2 % Topical LotionPSN4
198605dimethicone 20 MG/ML Topical LotionSCD4
198605dimethicone 2 % Topical LotionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4114-00Cetaphil Cracked Skin Repair473 mL in 1 BOTTLE, PUMPLOTION4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4114CETAPHIL CRACKED SKIN REPAIR (DIMETHICONE) LOTION [GALDERMA LABORATORIES, L.P.]4Current NDC, Legacy NDC, 1 package rows20231205_27d74e0f-8359-4c59-bf7f-acade7f4545c.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
0299-41140299-4114-00

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
Dimethicone92RU3N3Y1OACTIB
Medium-Chain TriglyceridesC9H2L21V7UIACT
Hydrogenated Castor OilZF94AP8MEYIACT
Lactic Acid, Unspecified Form33X04XA5ATIACT
Methoxy Peg-22/Dodecyl Glycol Copolymer2T6YOF5WQTIACT
MethylparabenA2I8C7HI9TIACT
Mineral OilT5L8T28FGPIACT
CeresinQ1LS2UJO3AIACT
Peg-7 Hydrogenated Castor OilWE09129TH5IACT
PropylparabenZ8IX2SC1OHIACT
Sodium LactateTU7HW0W0QTIACT
Sorbitan Isostearate01S2G2C1E4IACT
Urea8W8T17847WIACT
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 Cracked Skin RepairDIMETHICONEGalderma Laboratories, L.P.27d74e0f-8359-4c59-bf7f-acade7f4545c2023-11-30WarningsExact identifier
ndc (package): 0299-4114-00
ndc (product): 0299-4114
ndc11 (package): 00299411400
spl id: 54f6994b-a5ad-4dd6-82ec-c2578b46c89e
spl set id: 27d74e0f-8359-4c59-bf7f-acade7f4545c

Reported adverse events (FAERS/openFDA)#

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