Active Ingredients:
Menthol USP 12%
Point Relief Cold Spot Pain Relieving Gel
FDA Label NDC 51452-450
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 for the product Point Relief Cold Spot Pain Relieving (NDC 51452-450). 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:, keep out of reach of children., directions:, ingredients:, package labeling: 475ml, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses:
For temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, bruises, strains, and/ or sprains.
Warnings:
- For external use only
- Avoid contact with the 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.
Ingredients:
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua(Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Citric Acid, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, Methylsulfonylmethane (MSM), Polysorbate-80, Propyl Paraben, Propylene Glycol, SD-Alcohol 40B, Triethanolamine.
Package Labeling: 475Ml
Label (Label)
Package Labeling: 3.8L
Label2 (Label2)
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