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Drug Facts

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-07-21 05:10:25

Label at a glance#

ProductCetaphil Soothing Gel 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

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

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

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?

OTC - QUESTIONS SECTION

1-866-735-4137

PRINCIPLE DISPLAY PANEL - 16 OZ jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetaphil®

Soothing Gel Cream
0.5% Allantoin Skin Protectant

Dry, Irritated Skin

Fast absorbing gel-cream
helps relieves and prevent irritated skin.

Aloe Vera, Vitamin B5

Dermatologist Recommended
Sensitive Skin

         

NET WT 16 OZ (453 g)

Distributed By:
Galderma Laboratories, L.P.
Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

Made in Canada.

cetaphil.com
P55450-4

P55450-4 Soothing Gel Cream 16oz
P55450-4 Soothing Gel Cream 16oz

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

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
0299-41050299-4105-00, 0299-4105-05, 0299-4105-10, 0299-4105-15

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
Aloe Vera LeafZY81Z83H0XIACT
Sheanut OilO88E196QRFIACT
Caprylyl Glycol00YIU5438UIACT
Caprylyl/Capryl OligoglucosideE00JL9G9K0IACT
Citric Acid Monohydrate2968PHW8QPIACT
GlycerinPDC6A3C0OXIACT
Soybean Oil241ATL177AIACT
Sunflower Oil3W1JG795YIIACT
MethylpropanediolN8F53B3R4RIACT
PanthenolWV9CM0O67ZIACT
PantolactoneJ288D7O0JSIACT
PhenoxyethanolHIE492ZZ3TIACT
Polyisobutylene (1000 Mw)5XB3A63Y52IACT
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 Mw)1DXE3F3OZXIACT
TocopherolR0ZB2556P8IACT
Water059QF0KO0RIACT
Sorbitan Monooleate06XEA2VD56IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42023-12-11full-release2026-06-01 00:04:26

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 Soothing Gel CreamALLANTOINGalderma Laboratories, L.P.bab404f0-2f7a-4bac-b053-cbdc81c029b52025-11-24WarningsExact identifier
ndc (package): 0299-4105-15
ndc (package): 0299-4105-05
ndc (package): 0299-4105-00
ndc (package): 0299-4105-10
ndc (product): 0299-4105
ndc11 (package): 00299410510
ndc11 (package): 00299410500
ndc11 (package): 00299410505
ndc11 (package): 00299410515
spl id: 52cb1d3a-58d8-4ca4-97c2-73512fc53740
spl set id: bab404f0-2f7a-4bac-b053-cbdc81c029b5

Reported adverse events (FAERS/openFDA)#

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