PAIN RELIEVING BALM (MENTHOL, CAMPHOR, METHYL SALICYLATE) LINIMENT [INTERNATIONAL NATURE NUTRACEUTICALS, INC.]

PAIN RELIEVING BALM (MENTHOL, CAMPHOR, METHYL SALICYLATE) LINIMENT [INTERNATIONAL NATURE NUTRACEUTICALS, INC.]
PDF | XML

NDC 51367-010-58
Set ID 530b999d-8fbc-4c02-9c3e-7018f78badca
Category HUMAN OTC DRUG LABEL
Packager International Nature Nutraceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Menthol- 12%

    Camphor- 10%

    Methyl Salicylate- 23%

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

    • simple backache
    • arthritis
    • sprains
    • bruises
    • strains
  • Warnings

    For External Use Only

  • Do Not Use

    Do not use

    • on wounds or damaged skin
    • if allergic to salicylates
  • When using this product

    Avoid contact with the eyes, mouth, or mucous membranes

    Do not bandage tightly

  • Stop using and consult with physician if

    Condition worsens

    Symptoms persist for more than 7 days or clear up and occur again within a few days

  • Keep out of Reach of Children

  • Safety

    Pregnant or lactating women consult a doctor before use

    In case of accidental ingestion contact a doctor or Poision control center immediately

  • Directions

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age: Do not use, consult a doctor

  • Other Information

    Keep tightly closed

    Store in a cool and dry place

    Do not use if seal is broken

  • Inactive Ingredients

    Bees wax, Peppermint oil, Eucalyptus oil, Nutmeg oil

  • Packaging

    package
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING BALM 
    menthol, camphor, methyl salicylate liniment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.19 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5.78 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15.66 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-010-581 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2005
    Labeler - International Nature Nutraceuticals, Inc. (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chan Yat Hing Medicine Fty680069367manufacture(51367-010)

Related Drugs