Label: MUSCULAR BALM- capsaicin menthol methyl salicylate ointment

  • NDC Code(s): 60954-001-01, 60954-001-20
  • Packager: Eagle Indo Pharma, PT
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 10, 2019

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  • Active Ingredients

    Capsaicin 0.15%
    Menthol 13.5%
    Methyl Salicylate 30%


  • 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

  • INGREDIENTS AND APPEARANCE
    MUSCULAR BALM 
    capsaicin menthol methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.15 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL13.5 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTOL (UNII: RV6J6604TK)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60954-001-011 in 1 BOX05/14/2010
    1NDC:60954-001-2020 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/14/2010
    Labeler - Eagle Indo Pharma, PT (728682519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eagle Indo Pharma, PT728682519manufacture(60954-001)
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