Active Ingredient
Dimethicone 1%
Cracked Heel Repair Balm Cream
FDA Label NDC 20276-042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Delta Brands Inc. for the product Cracked Heel Repair Balm (NDC 20276-042). 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, when using this product, stop use and ask a doctor if:, do not use on, keep out of reach of children, 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 prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ■ temporarily 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:
■ conditon worsens ■ symptoms last more than 7 days or clear up and occur again wihtin a few days
Do Not Use On
■ deep or puncture wounds ■ animal bites ■ serious burns
Keep Out Of Reach Of Children
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
allantoin, butyrospermum parkii (shea) butter, carbomer, ceteareth-20, cetearyl alcohol, disodium EDTA, glycerin, glyceryl stearate, phenoxyethanol, petrolatum, sodium hydroxide, stearic acid, triethylene glycol, water
Package Label.Principal Display Panel
Package Label (Lsscrckedheelblm3ozlbl)
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