Active Ingredient
MENTHOL 1.2%
Cooling
FDA Label NDC 82551-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Full Eight Inc for the product Cooling (NDC 82551-119). 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, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TOPICAL ANALGESIC
Use
Temporary relief from minor aches and pain such as cramps, sore muscles, arthritis, muscle strains, and bruises
Warnings
For external use only
Flammable: Keep away from excessive heat and open flame
Ask a doctor before use if you have: Sensitive skin
When using this product: Avoid contact with eyes or mucous membranes
- Do not apply to wounds or damaged skin
- Do not use with other ointments, creams, sprays, or liniments
- Do not apply to irritated skin or if excessive irritation develops
- Do not bandage
- Wash hands after use with cool water
- Do not use with heating pad or device
Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur
If pregnant or breast-feeding: Ask a doctor before use
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Directions
Adults 18 years of age and older: Massage into skin at affected areas before bed & when symptoms arise
Inactive Ingredients
Purified water, Glycerin, SD Alcohol, Carbomer, Olive Oil, Tetrasodium EDTA, Spearmint Oil, Lemongrass oil, Eucalyptus Oil, Peppermint Oil, Camphor, Triethanolamine, F D & C Blue #1, DMDM Hydantoin
Questions Or Comments?
704-461-3009 • [email protected]
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