CETAPHIL BABY SOOTHE AND PROTECT CREAM- allantoin cream 
Galderma Laboratories, L.P.

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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 ■Helps 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 as needed

Inactive Ingredients

BUTYROSPERMUM PARKII (SHEA) OIL, CALENDULA OFFICINALIS FLOWER EXTRACT, CAPRYLYL/CAPRYL GLUCOSIDE, CAPRYLYL GLYCOL, 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

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

PRINCIPLE DISPLAY PANEL - 6 oz tube

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®

baby

Soothe & Protect
Cream
with Allantoin -
Skin Protectant

         

Baby's Sensitive Skin

Protects baby's delicate skin 
and prevents dry, chafed or
cracked skin

Soothing calendula


(SEAL) Dermatologist tested

NET WT 6 oz (170 g)

P55465-1 Cet Baby SootheProtect Cream 6oz Tube final
CETAPHIL BABY SOOTHE AND PROTECT CREAM 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4103
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
Sheanut Oil (UNII: O88E196QRF)  
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
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:0299-4103-05170 g in 1 TUBE; Type 0: Not a Combination Product02/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01602/03/2020
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
G Production Inc.251676961manufacture(0299-4103)

Revised: 11/2023
Document Id: 01b1ef2f-f664-450b-9fc1-81c61d1ed6b1
Set id: 38254e03-3716-4e45-86b7-06430ebadc86
Version: 4
Effective Time: 20231122
 
Galderma Laboratories, L.P.