Otc - Active Ingredient
Active Ingredient
Allantoin, 0.5%
Cool Melon
FDA Label NDC 11084-042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Deb Usa, Inc. for the product Cool Melon (NDC 11084-042). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Skin protectant
Indications & Usage
Uses
Helps relieve chapped or cracked skin
Helps prevent and protect from the drying effects of wind and cold weather
Warnings
Warnings
For external use only
Otc - When Using
When using this product avoid contact with the eyes.
In case of eye contact, flush with water.
Otc - 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.
Dosage & Administration
Directions
Apply to clean hands
Rub in well
Re-apply after handwashing or as needed
Inactive Ingredient
Inactive Ingredients
Water, Cetyl Esters, Petrolatum, Isoproply Palmitate, Stearyl Alcohol, Ceteareth-20, Chloroxylenol, Carbomer, PEG-75 Lanolin, Hydroxyethylcellulose, Methylparaben, Ethanolamine, Propylparaben, Fragrance.
Package Label.Principal Display Panel
Cool Melon
Medicated Skin Cream
Non-Greasy, Silicone-Free
Conditions and relieves dry, hard-working hands
deb
Proudly made in the USA by Deb
40227-00-100
1 Liter - 33.8 Fluid Ounces
* Please review the disclaimer below.
