Active Ingredients
Capsaicin 0.15%
Menthol 13.5%
Methyl Salicylate 30%
Muscular Balm Ointment
FDA Label NDC 60954-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eagle Indo Pharma, Pt for the product Muscular Balm (NDC 60954-001). 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, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
External Analgesic
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 getting into the eyes or on mucus membranes.
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
■ 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
Keep Out Of Reach Of Children
to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center Immediately
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 Ingredients
eucalyptol, fragrance, paraffin wax and petroleum jelly
Package Label
Package Label (Msclrblmusarev)
* Please review the disclaimer below.
