CETAPHIL SOOTHING GEL CREAM- allantoin cream 
Galderma Laboratories, L.P.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients......Purpose

Allantoin 0.5%......Skin Protectant

Uses

Temporarily protects minor: ●cuts
●scrapes ●burns ■helps prevent and temporarily
protects and helps relieve chafed, chapped or
cracked skin

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 as needed

Inactive Ingredients

ALOE BARBADENSIS LEAF JUICE POWDER, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CAPRYLYL/CAPRYL GLUCOSIDE, CITRIC ACID, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYLPROPANEDIOL, PANTHENOL, PANTOLACTONE, PHENOXYETHANOL, POLYISOBUTENE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, TOCOPHEROL, WATER

Questions or comments?

1-866-735-4137

PRINCIPLE DISPLAY PANEL - 8 OZ TUBE

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®

Soothing
Gel Cream
with Aloe

Irritated, Sensitive Skin

Fast absorbing formula
helps rescue, prevent and
relieve dry, stressed skin

Skin Protectant Allantoin

Five Skin Sensitivity Sign

         

NET WT 8 OZ (226 g)

Distributed By:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

Made in Canada.

cetaphil.com
P55452-1

052229 P55452-1 TUBE Cetaphil Soothing Gel Cream 8oz US (OTC) OL
CETAPHIL SOOTHING GEL CREAM 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Sheanut Oil (UNII: O88E196QRF)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Caprylyl/Capryl Oligoglucoside (UNII: E00JL9G9K0)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Soybean Oil (UNII: 241ATL177A)  
Sunflower Oil (UNII: 3W1JG795YI)  
Methylpropanediol (UNII: N8F53B3R4R)  
Panthenol (UNII: WV9CM0O67Z)  
Pantolactone, (R)- (UNII: J288D7O0JS)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polyisobutylene (1000 Mw) (UNII: 5XB3A63Y52)  
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) (UNII: 1DXE3F3OZX)  
Tocopherol (UNII: R0ZB2556P8)  
Water (UNII: 059QF0KO0R)  
Sorbitan Monooleate (UNII: 06XEA2VD56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4105-0010 g in 1 TUBE; Type 0: Not a Combination Product02/17/2020
2NDC:0299-4105-0585 g in 1 TUBE; Type 0: Not a Combination Product02/17/2020
3NDC:0299-4105-10226 g in 1 TUBE; Type 0: Not a Combination Product02/17/2020
4NDC:0299-4105-15453 g in 1 JAR; Type 0: Not a Combination Product02/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/17/2020
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
G Production Inc.251676961manufacture(0299-4105)

Revised: 3/2022
Document Id: d2c02d75-1a81-4bcf-af5e-184f8fd9d6e7
Set id: bab404f0-2f7a-4bac-b053-cbdc81c029b5
Version: 3
Effective Time: 20220328
 
Galderma Laboratories, L.P.