EAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]

EAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]
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NDC 43405-010-01, 43405-010-85
Set ID 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0
Category HUMAN OTC DRUG LABEL
Packager Borden Company (Private) Limited
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Menthol 14.5%
    Methyl Salicylate 30%


  • Purpose

    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

    alcohol, camphor, thymol

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    EAGLE  EXTRA STRENGTH
    menthol methyl salicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14.5 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43405-010-011 in 1 BOX
    1NDC:43405-010-8585 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(43405-010)

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