MUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]

MUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]
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NDC 43405-007-01, 43405-007-20
Set ID ed79f14e-6b3d-4bf2-9c34-d019c1ba2582
Category HUMAN OTC DRUG LABEL
Packager Borden Company (Private) Limited
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Capsaicin 0.15%
    Menthol 13.5%
    Methyl Salicylate 30%


  • Purpose

    External Analgesic

    External Analgesic

    External Analgesic

  • Use

    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 mucous membranes.

  • When using this product

    ■ do not apply to wounds 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



    image of package label


  • INGREDIENTS AND APPEARANCE
    MUSCULAR BALM 
    capsaicin menthol methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-007
    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:43405-007-011 in 1 BOX05/14/2010
    1NDC:43405-007-2020 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 - Borden Company (Private) Limited (595109711)

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