Label: MEDICATED BALM ARTHRITIS PAIN RELIEVING CREAM- camphor, menthol cream

  • NDC Code(s): 51367-032-75
  • Packager: International Nature Nutraceuticals Inc.
  • 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 September 26, 2017

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  • Active Ingredients

    Camphor 9%

    Menthol 16%

  • Uses

    The temporary relief of minor aches and pains of muscles and joints due to:

    Simple backache

    Sprains

    Bruises

    Arthritis 

  • Warnings

    For External use only

  • Do not use:

    On wound or damaged skin

    Otherwise than as directed

  • Stop using and consult with doctor if:

    Condition worsens

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

    allergic to salicylates or aspirin

  • Other Information

    Keep bottle tightly closed, store in a cool and dry place

    Do not use if seal is broken

  • Directions

    Adults and children 2 years of age and older: Apply to affected area 3-4 times daily

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

  • Keep out of reach of children

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

  • Inactive Ingreidents

    Eucalyptus oil

    Petrolatum

    Cinnamon bark oil

    Paraffin

    Ceresin

    Peppermint oil

  • Pregnant or lactating women

    Consult a doctor before using

  • When using this product

    Avoid contact with the eyes, mouth, or mucous membranes

    Do not bandage tightly 

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MEDICATED BALM ARTHRITIS PAIN RELIEVING CREAM 
    camphor, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)6.75 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-032-751 in 1 PACKAGE; Type 0: Not a Combination Product10/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2017
    Labeler - International Nature Nutraceuticals Inc. (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Luoyang MuChun pharmaceutical Co., LTD526916382manufacture(51367-032)
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