Topicool Pain Relief
FDA Label NDC 57698-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tensproducts, Inc. for the product Topicool Pain Relief (NDC 57698-100). 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 use, ask a doctor or pharmacist if you are, stop use and consult a doctor if, general precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Camphor 0.4%

Menthol 4.5%

Purpose:

External Analgesic

External Analgesic

Uses:

For the temporary relief of

  • arthritis
  • backache
  • sprains
  • strains

Warnings:

Use only as directed.
For external use only.

Do Not Use

  • with other topical products
  • on open wounds or damaged skin

Ask A Doctor Or Pharmacist If You Are

pregnant or breastfeeding

Stop Use And Consult A Doctor If

symptoms persist for more than 7 days

General Precautions


Avoid contact with eyes
Do not bandage tightly
Keep away from excessive heat or open flame

Keep Out Of Reach Of Children.

In case of ingestion, seek professional assistance and contact poison control immediately.

Directions:

  • Adults and children 2 years of age and older apply to affected area not more than 4 times daily
  • rub in thoroughly until gel is absorbed

Other Information:

Store at room temperature with cap closed.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Boswellia Serrata Extract, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Alcohol, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Tetrasodium EDTA, Triethanolamine, Uncaria Tomentosa (Cat's Claw) Extract, Zemea Propanediol

Questions Or Comments?

(866) 449-1010 or www.tensproducts.com

Principal Display Panel - 113.4 G Tube Label

TopiCool™
Pain relief gel with Cat's Claw

NET WT 4 OZ (113.4g)

Principal Display Panel (113.4 g Tube Label)

Principal Display Panel (113.4 g Tube Label)

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