FDA.reportPublic FDA data

Cetaphil Baby Soothe and Protect Cream

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2023-11-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:45

Label at a glance#

ProductCetaphil Baby Soothe and Protect Cream
Active ingredientAllantoin
Label structure7 sections

Indications and 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.

Dosage and administration

■Apply as needed

Label contents#

Full prescribing information#

Active ingredients......Purpose

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%......Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

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 as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#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
P55465-1 Cet Baby SootheProtect Cream 6oz Tube final

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
241509allantoin 0.5 % Topical CreamPSN4
241509allantoin 5 MG/ML Topical CreamSCD4
241509allantoin 0.5 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4103-05Cetaphil Baby Soothe and Protect Cream170 g in 1 TUBECREAM1704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4103CETAPHIL BABY SOOTHE AND PROTECT CREAM (ALLANTOIN) CREAM [GALDERMA LABORATORIES, L.P.]4Current NDC, Legacy NDC, 1 package rows20231128_38254e03-3716-4e45-86b7-06430ebadc86.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-41030299-4103-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Allantoin344S277G0ZACTIB
Sheanut OilO88E196QRFIACT
Calendula Officinalis FlowerP0M7O4Y7YDIACT
Caprylyl Glycol00YIU5438UIACT
Caprylyl/Capryl OligoglucosideE00JL9G9K0IACT
Citric Acid Monohydrate2968PHW8QPIACT
GlycerinPDC6A3C0OXIACT
Soybean Oil241ATL177AIACT
Sunflower Oil3W1JG795YIIACT
MethylpropanediolN8F53B3R4RIACT
PanthenolWV9CM0O67ZIACT
Pantolactone, (R)-J288D7O0JSIACT
PhenoxyethanolHIE492ZZ3TIACT
Polyisobutylene (1000 Mw)5XB3A63Y52IACT
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 Mw)1DXE3F3OZXIACT
TocopherolR0ZB2556P8IACT
Water059QF0KO0RIACT
Sorbitan Monooleate06XEA2VD56IACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Baby Soothe and Protect CreamALLANTOINGalderma Laboratories, L.P.38254e03-3716-4e45-86b7-06430ebadc862023-11-22WarningsExact identifier
ndc (package): 0299-4103-05
ndc (product): 0299-4103
ndc11 (package): 00299410305
spl id: 01b1ef2f-f664-450b-9fc1-81c61d1ed6b1
spl set id: 38254e03-3716-4e45-86b7-06430ebadc86

Reported adverse events (FAERS/openFDA)#

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