Muscular Balm Ointment
FDA Label NDC 43405-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Borden Company (private) Limited for the product Muscular Balm (NDC 43405-007). 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, when using this product, stop use and ask a doctor if, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Capsaicin 0.15%
Menthol 13.5%
Methyl Salicylate 30%


Purpose

External Analgesic

Uses

For the temporary relief of minor pains and aches of muscles and joints  associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

  • Avoid contact with mucus membranes and eyes.


When Using This Product

  • do not apply to wound or damaged skin.
  • do not bandage tightly
  • do not use if excessive irritation of the skin develops
  • do not use otherwise than as directed

Stop Use And Ask A Doctor If

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • pain persists for more than 10 days
  • redness is present
  • conditions affect children under 12 years of age

Dosage & Administration

Directions
  • Adults and children 12 years of age and over: Apply to affected area not more than 3 to 4 time daily.
  • Children under 12 years of age:consult a doctor

Inactive Ingredient

Inactive Ingredients eucalyptol, fragrance, paraffin wax and petroleum jelly

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Package Label

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