Active Ingredients
Zinc Oxide 20.5%
Gl Health Barrier Skin Protectant Cream
FDA Label NDC 82897-379
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gl Health, Inc. for the product Gl Health Barrier Skin Protectant (NDC 82897-379). 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, when using this product, stop use and talk to a doctor if, keep out of the reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
• Helps treat and prevent diaper rash
• Protects chafed skin due to wetness and helps seal out wetness
Warnings
For external use only
When Using This Product
avoid contact with the eyes
Stop Use And Talk To A Doctor If
condition worsens or does not improve after 7 days
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately
Directions
Apply a layer of Barrier® to skin area you wish to protect. Change wet & spoiled diapers immediately. Clean the diaper area & allow to dry. Apply cream liberally & as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers for a long period of time.
Inactive Ingredients
Aloe Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Oil, Tocopheryl Acetate (Vitamin E)
Questions?
Call 1-708-381-0334
Package Labeling:
Label (Label)
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