Label: EAGLE GREEN BALM- camphor menthol ointment

  • NDC Code(s): 43405-100-01, 43405-100-20
  • Packager: Borden Company (Private) Limited
  • 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 November 5, 2021

If you are a consumer or patient please visit this version.

  • 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 into the eyes or on mucous membranes ■ do not apply to wounds and 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

    ■ Condition 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

    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 use

  • Other Information

    ■ Store in a cool dry place

  • Inactive Ingredients

    fragrance, paraffin, peppermint oil, petrolatum

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    EAGLE GREEN BALM 
    camphor menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-100
    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
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43405-100-011 in 1 BOX05/14/2018
    1NDC:43405-100-2020 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 - Borden Company (Private) Limited (595109711)