Thera Plus Extra Strength Muscle Rub Topical Analgesic Gel
FDA Label NDC 80684-139

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 Extra Strength Muscle Rub Topical Analgesic (NDC 80684-139). 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, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Menthol 2.5%

Purpose

Topical analgesic

Uses

temporarily relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

For external use only.

Do Not Use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with an arthritis-like condition

When Using This Product

  • avoid contact with eyes and mucous membranes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • excessive skin irritation occurs
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and then occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Direction

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor 

Other Information

  • store at room temperature 68° - 72°F (20° - 22°C).

Inactive Ingredients

camphor,carbomer, DMDM hydantoin, isoceteth, isopropyl alcohol,PEG-40 hydrogenated castor oil,purified water,sodium hydroxide

Questions?

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