CETAPHIL CRACKED SKIN REPAIR BALM- dimethicone cream

Cetaphil Cracked Skin Repair Balm by

Drug Labeling and Warnings

Cetaphil Cracked Skin Repair Balm by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., G Production Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient......Purpose

Dimethicone 1%......Skin Protectant

PURPOSE

KEEP OUT OF REACH OF CHILDREN

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  

Warnings

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

● Apply generously to affected area as needed

Inactive Ingredients

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?

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

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

INGREDIENTS AND APPEARANCE

CETAPHIL CRACKED SKIN REPAIR BALM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Docosanol (UNII: 9G1OE216XY)
Sheanut Oil (UNII: O88E196QRF)
Caprylyl Glycol (UNII: 00YIU5438U)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetyl Alcohol (UNII: 936JST6JCN)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Sodium Cetostearyl Sulfate (UNII: 7ZBS06BH4B)
Sodium Polyacrylate (2500000 Mw) (UNII: 05I15JNI2J)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4115-00	1 in 1 CARTON	05/01/2021
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/01/2021

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4115)