Cetaphil Cracked Skin Repair Lotion
FDA Label NDC 0299-4114

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 (NDC 0299-4114). 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 - 473 ml pump label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients......Purpose

Dimethicone 2%......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

CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED CASTOR OIL, LACTIC ACID, METHOXY PEG-22/DODECYL GLYCOL COPOLYMER, METHYLPARABEN, MINERAL OIL, OZOKERITE, PEG-2 HYDROGENATED CASTOR OIL, PEG-7 HYDROGENATED CASTOR OIL, PROPYLPARABEN, SODIUM LACTATE, SORBITAN ISOSTEARATE, UREA, 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 - 473 Ml Pump Label

New
Dermatologist #1 Recommended Facial Skincare Brand
Cetaphil®


Cracked Skin Repair Lotion
Skin Protectant

Very rough and cracked skin

With Urea to moisturize for 24 hours             

Clinically proven ingredient to protect
and soothe immediately

5 skin sensitivity signs

16 FL OZ (473 mL)

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