Active Ingredients......Purpose
Allantoin 0.5%......Skin Protectant
Cetaphil Baby Soothe And Protect Cream
FDA Label NDC 0299-4103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Galderma Laboratories, L.p. for the product Cetaphil Baby Soothe And Protect Cream (NDC 0299-4103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients......purpose, uses, warnings, directions, inactive ingredients, questions or comments?, principle display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
