CETAPHIL CRACKED SKIN REPAIR- dimethicone lotion 
Galderma Laboratories, L.P.

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Drug Facts

Active ingredients......Purpose

Dimethicone 2%......Skin protectant

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

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?

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

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
CETAPHIL CRACKED SKIN REPAIR 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)  
Methoxy Peg-22/Dodecyl Glycol Copolymer (UNII: 2T6YOF5WQT)  
Methylparaben (UNII: A2I8C7HI9T)  
Mineral Oil (UNII: T5L8T28FGP)  
Ceresin (UNII: Q1LS2UJO3A)  
Peg-7 Hydrogenated Castor Oil (UNII: WE09129TH5)  
Propylparaben (UNII: Z8IX2SC1OH)  
Sodium Lactate (UNII: TU7HW0W0QT)  
Sorbitan Isostearate (UNII: 01S2G2C1E4)  
Urea (UNII: 8W8T17847W)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4114-00473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/01/2021
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
G Production Inc.251676961manufacture(0299-4114)

Revised: 11/2023
Document Id: 54f6994b-a5ad-4dd6-82ec-c2578b46c89e
Set id: 27d74e0f-8359-4c59-bf7f-acade7f4545c
Version: 4
Effective Time: 20231130
 
Galderma Laboratories, L.P.