Thera Plus Cool And Heat Pain Relieving Gel Menthol Liquid
FDA Label NDC 80684-097

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Cool And Heat Pain Relieving Gel Menthol (NDC 80684-097). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warnings

For external use only.

Test on a small patch of skin before applying generously.

Flammable •keep away from fire or flame

When Using This Product

• use only as directed • avoid contact with the eyes and mucous membranes • do not apply to wounds or damaged skin • do not
bandage tightly • do not use with heating pads or other heating devices • if redness is present, discontinue use and consult a doctor • if skin irritation occurs, discontinue use • a transient burning sensation may occur upon application but generally disappears in several days

Stop Use And Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but no more than 3 to 4 times daily • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor 

Other Information

  • store at 20° - 25°C (68° - 77°F)
  • store in a cool dry place away from direct sunlight

Inactive Ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, sd alcohol, triethanoamine, water

Questions Or Comments?

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