CETAPHIL BABY SOOTHE AND PROTECT CREAM- allantoin cream

Cetaphil Baby Soothe and Protect Cream by

Drug Labeling and Warnings

Cetaphil Baby Soothe and Protect Cream by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., G Production Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients......Purpose

Allantoin 0.5%......Skin Protectant

PURPOSE

KEEP OUT OF REACH OF CHILDREN

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

All trademarks are the property of their respective owners

Made in Canada

Cetaphil.com

PRINCIPLE DISPLAY PANEL

Cetaphil®

baby

Soothe &
Protect
Cream

         

Allantoin
Skin Protectant

with organic calendula

Face & Body

Prevents dry, chaffed or
cracked skin

Protects baby's delicate skin from cold or windy weather

NET WT 6 OZ (170 g)

[SEAL]

DERMATOLOGIST TESTED

INGREDIENTS AND APPEARANCE

CETAPHIL BABY SOOTHE AND PROTECT CREAM 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4103
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4103-05	170 g in 1 TUBE; Type 0: Not a Combination Product	02/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/03/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4103)