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

EAGLE GREEN BALM (CAMPHOR MENTHOL) OINTMENT [EAGLE INDO PHARMA, PT]
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NDC 60954-100-01, 60954-100-20
Set ID 6f79b43d-ab35-2b71-e053-2991aa0a1202
Category HUMAN OTC DRUG LABEL
Packager Eagle Indo Pharma, PT
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENTS

    Camphor 11%
    Menthol 15%

  • Purpose

    Analgesic

    Analgesic

  • INDICATIONS

    For the temporary relief of minor pains and aches of muscles and joints associated with simple backache,arthritis, strains, bruises and sprains

  • WARNING

    EXTERNAL USE ONLY

    ■Do not apply towounds and damaged skin

    ■Avoid contact with eyes

    ■Do not bandage tightly

    ■If condition worsens, or if symptoms persist for more than 7 days discontinue use and consult a doctor

  • Keep out of reach of children

    ■Keep this drug out of reach of children

    ■In case of accidental ingestion seek doctor or Poison Control Center

  • DIRECTIONS

    for adults and children 2 years of age and older apply to affected area not more than 3 - 4 times daily. Children under 2 years of ageconsult a doctor before use

  • Other Information

    Do not use otherwise than directed

    Keep in a cool dry place

  • Inactive Ingredients

    Vanillin, Clove Oil, petroleum Jelly, Paraffin Wax

  • Package Label

    Box Label

  • INGREDIENTS AND APPEARANCE
    EAGLE GREEN BALM 
    camphor menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-100
    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
    CLOVE OIL (UNII: 578389D6D0)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60954-100-011 in 1 BOX05/14/2018
    1NDC:60954-100-2020 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 finalpart34805/14/2018
    Labeler - Eagle Indo Pharma, PT (728682519)

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