Label: EAGLE MEDICATED AROMATIC- camphor menthol methyl salicylate oil

  • NDC Code(s): 43405-009-01, 43405-009-03, 43405-009-08, 43405-009-12, view more
    43405-009-13, 43405-009-24
  • 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 June 30, 2022

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  • Active Ingredients

    Camphor 7%

    Menthol 16%
    Methyl Salicylate 35%

  • Purpose

    External Analgesic

    External Analgesic

    External Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joint associated with ■ simple backache ■ arthritis ■ strains

    ■ bruises ■ sprains

  • Warnings

    ■ For external use only ■ Avoid getting into eyes and mucous membranes

  • When using this product

    ■ do not apply to wound or damaged skin ■ do not bandage tightly ■ do not use otherwise than as directed

  • Stop use and ask a doctor if

    ■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ pain persists for more than 10 days ■ redness is present ■ conditions affect children under 12 years of age

  • Keep this drug out of reach of children

    to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use

  • Directions

    ■ adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily. ■ apply liberally and gently rub into affected area ■ children under 12 years of age, consult a doctor before using.

  • Inactive ingredients

    eucalyptus oil, light mineral oil, spike lavender oil

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    EAGLE  MEDICATED AROMATIC
    camphor menthol methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)7 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE35 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43405-009-011 in 1 BOX06/15/2015
    1NDC:43405-009-2424 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:43405-009-131 in 1 BOX06/15/2015
    2NDC:43405-009-033 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    3NDC:43405-009-081 in 1 BOX06/06/2022
    38 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    4NDC:43405-009-121 in 1 BOX06/20/2022
    412 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2015
    Labeler - Borden Company (Private) Limited (595109711)
    Establishment
    NameAddressID/FEIBusiness Operations
    Borden Company (Private) Limited595109711manufacture(43405-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eagle Indo Pharma, PT728682519manufacture(43405-009)
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