Point Relief Cold Spot Pain Relieving Roll-on Liquid
FDA Label NDC 51452-037

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 Roll-on (NDC 51452-037). 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:, do not apply, keep out of reach of children, directions:, other ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

menthol - USP 14%

Purpose:

external 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 sevan 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 fimes per day.

Other Ingredients:

aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, carbomer, chondroitin sulfate, eucalyptus globulus oil, glucosamine sulfate, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methylisothiazolinone, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B, triethanolamine

Package Labeling:

Label7 (Label7)

Label7 (Label7)

* Please review the disclaimer below.