Point Relief Coldspot Pain Relieving Gel
FDA Label NDC 51452-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fabrication Enterprises Inc for the product Point Relief Coldspot Pain Relieving (NDC 51452-007). 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 drug facts, active ingredients:, purpose:, uses:, warnings:, keep out of reach of children, directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients:
Menthol 12.50%
Purpose:
Topical Analgesic
Uses:
For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains, and/or sprains
Warnings:
•
For external use only
• Avoid contact with eyes
• Do not apply to open wounds or damaged skin
• If symptoms persist for more than seven days, discontinue use and consult physician
Keep Out Of Reach Of Children
• If swallowed, consult physician
• Do not bandage tightly
Directions:
Apply directly to affected area. Do not use more than four times per day.
Inactive Ingredients:
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Arnica Montana Extract, Boswellia Serrata Extract, Bromelain, Citric Acid, Diazolidinyl Urea, Dimethyl Sulfone, Eucalyptus Globulus Leaf Oil, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Ilex Paraguariensis Leaf Extract, Mentha Piperita (Peppermint) Oil, Methyl Salicylate, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Triethanolamine, Water (Aqua)
Package Labeling:
Label (Label)
* Please review the disclaimer below.
