Label at a glance#

ProductCetaphil Cracked Skin Repair Balm

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

Contacts and useful links#

PhoneLabel contact1-866-735-4137

Label contents#

Full prescribing information#

Active ingredient......Purpose

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%......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

BEHENYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CETYL ALCOHOL, CITRIC ACID, ETHYLHEXYLGLYCERIN, GLYCERIN, SODIUM CETEARYL SULFATE, SODIUM POLYACRYLATE, WATER, YEAST BETAGLUCAN

Questions or comments?

OTC - QUESTIONS SECTION

1-866-735-4137

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

All trademarks are the property of their respective owners

Made in Canada

cetaphil.com

PRINCIPLE DISPLAY PANEL - 3 oz carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermatologist Recommended
For Sensitive Skin

Cetaphil^®

Cracked Skin
Repair Balm
Skin Protectant Dimethicone

Very Dry, Cracked Sensitive Skin

Instantly protects and
soothes to promote
healing of deeply
cracked skin

Beta Glucan

5 skin sensitivity signs

NET WT 3 OZ ( 85 g)

P56442-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
200010	dimethicone 1 % Topical Cream	PSN	3
200010	dimethicone 10 MG/ML Topical Cream	SCD	3
200010	dimethicone 1 % Topical Cream	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0299-4115-00	Cetaphil Cracked Skin Repair Balm	1 in 1 CARTON	CREAM	1		3
0299-4115-00	Cetaphil Cracked Skin Repair Balm	85 g in 1 TUBE	CREAM	85		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0299-4115	CETAPHIL CRACKED SKIN REPAIR BALM (DIMETHICONE) CREAM [GALDERMA LABORATORIES, L.P.]	3	Current NDC, Legacy NDC, 2 package rows	20231205_5efb3ef0-6ee9-4ef8-b81e-90bd1825c956.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Cetaphil Cracked Skin Repair Balm
Dimethicone
Docosanol
Sheanut Oil
Caprylyl Glycol
Cetostearyl Alcohol
Cetyl Alcohol
Citric Acid Monohydrate
Ethylhexylglycerin
Glycerin
Sodium Cetostearyl Sulfate
Sodium Polyacrylate (2500000 Mw)
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0299-4115	0299-4115-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dimethicone	92RU3N3Y1O	ACTIB
Docosanol	9G1OE216XY	IACT
Sheanut Oil	O88E196QRF	IACT
Caprylyl Glycol	00YIU5438U	IACT
Cetostearyl Alcohol	2DMT128M1S	IACT
Cetyl Alcohol	936JST6JCN	IACT
Citric Acid Monohydrate	2968PHW8QP	IACT
Ethylhexylglycerin	147D247K3P	IACT
Glycerin	PDC6A3C0OX	IACT
Sodium Cetostearyl Sulfate	7ZBS06BH4B	IACT
Sodium Polyacrylate (2500000 Mw)	05I15JNI2J	IACT
Water	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Cracked Skin Repair Balm	DIMETHICONE	Galderma Laboratories, L.P.	5efb3ef0-6ee9-4ef8-b81e-90bd1825c956	2023-11-30	Warnings	Exact identifier ndc (package): 0299-4115-00 ndc (product): 0299-4115 ndc11 (package): 00299411500 spl id: 40277fde-372e-4ded-b7f8-15168d11582a spl set id: 5efb3ef0-6ee9-4ef8-b81e-90bd1825c956

Reported adverse events (FAERS/openFDA)#

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