Cetaphil Baby Healing Ointment
FDA Label NDC 0299-4141

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 Healing (NDC 0299-4141). 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 ingredient......purpose, uses, warnings, directions, inactive ingredients, questions?, principle display panel - 12 oz (340 g) jar, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient......Purpose

Petrolatum 71.5%......Skin Protectant

Uses

● temporarily protects minor:
   ● cuts ● scrapes ● burns
● temporary protects and helps relieve chafed, chapped or cracked skin
● helps prevent and protect from the drying effects of wind and cold weather
● helps treat and prevent diaper rash
● protects chafed skin associated with diaper rash and helps protect from wetness

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
● for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. 

Inactive Ingredients

CETEARYL ETHYLHEXANOATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, BEESWAX, MICROCRYSTALLINE WAX, TOCOPHERYL ACETATE (VITAMIN E ACETATE)

Questions?

1-866-735-4137

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

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com
P57538-0

Principle Display Panel - 12 Oz (340 G) Jar

Cetaphil®

baby
Healing
Ointment

Baby's Sensitive Skin

Skin Protectant          

NATIONAL ECZEMA
ASSOCIATION LOGO

NET WT 12 OZ (340 g)

* Please review the disclaimer below.