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 - 16 OZ jar

NEW LOOK

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
P55450-3

CETAPHIL SOOTHING GEL CREAM
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0299-4105
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0299-4105-00	10 g in 1 TUBE; Type 0: Not a Combination Product	02/17/2020
2	NDC:0299-4105-05	85 g in 1 TUBE; Type 0: Not a Combination Product	02/17/2020
3	NDC:0299-4105-10	226 g in 1 TUBE; Type 0: Not a Combination Product	02/17/2020
4	NDC:0299-4105-15	453 g in 1 JAR; Type 0: Not a Combination Product	02/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	02/17/2020

Labeler - Galderma Laboratories, L.P. (047350186)

Name	Address	ID/FEI	Business Operations
Establishment
G Production Inc.		251676961	manufacture(0299-4105)