Cetaphil Cracked Skin Repair Balm Cream
FDA Label NDC 0299-4115

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 Cracked Skin Repair Balm (NDC 0299-4115). 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 or comments?, principle display panel - 3 oz carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient......Purpose

Dimethicone 1%......Skin Protectant

Uses

● helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
● temporary protects minor:
   ● cuts ● scrapes ● burns
● helps prevent and 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 generously to affected area as needed

Inactive Ingredients

BEHENYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CETYL ALCOHOL, CITRIC ACID, ETHYLHEXYLGLYCERIN, GLYCERIN, SODIUM CETEARYL SULFATE, SODIUM POLYACRYLATE, WATER, YEAST BETAGLUCAN

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 - 3 Oz Carton

New
Dermatologist #1 Recommended
Facial Skincare Brand
Cetaphil®

Cracked Skin
Repair Balm
Skin Protectant

Very rough and cracked skin

With Beta Glucan to help
soothe

Relieves and softens                 

Protects cracked skin to
promote healing

Gentle enough for daily
use on sensitive skin

5 skin sensitivity signs

NET WT 3 OZ ( 85 g)

* Please review the disclaimer below.