EAGLE BALM (CAMPHOR MENTHOL) OINTMENT [EAGLE INDO PHARMA, PT]

EAGLE BALM (CAMPHOR MENTHOL) OINTMENT [EAGLE INDO PHARMA, PT]
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NDC 60954-010-01, 60954-010-19
Set ID 87614869-9675-2c76-e053-2a95a90a48a9
Category HUMAN OTC DRUG LABEL
Packager Eagle Indo Pharma, PT
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Menthol 15%

    Camphor 11%

  • Purpose

    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

  • When using this product

    ■ Avoid getting itno the eyes or on mucous membranes ■do not apply to wounds or damaged skin ■do not bandage tightly or use with a heating pad ■do not use otherwise than as directed

  • Stop use and ask a doctor if

    ■Conditions worsens ■symptoms persist for more than 7 days or clear up and occur again within a few days ■redness is present

  • Keep out of reach of children

    In case of accidental ingestion contact a doctor or Poison Control Center immediately.

  • Directions

    ■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■children under 12 years of age, consult a doctor before using

  • Other Information

    ■ Store in a a cool, dry place

  • Inactive Ingredients

    fragrance, paraffin, peppermint oil, petrolatum

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    EAGLE BALM 
    camphor menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60954-010-011 in 1 BOX04/15/2019
    1NDC:60954-010-1919.8 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 finalpart34804/15/2019
    Labeler - Eagle Indo Pharma, PT (728682519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eagle Indo Pharma, PT728682519manufacture(60954-010)

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