LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]

LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]
PDF | XML

NDC 53145-047-01
Set ID 08819ad0-97c2-49bd-b923-535b94a27167
Category HUMAN OTC DRUG LABEL
Packager Menper Distributors, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients

    Methyl salicyate

  • PURPOSE

    Purpose

    External Analgesic

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of minor aches and pains of muscle and joints associated with simple backache; arthritis, strains and sprains.
  • WARNINGS

    Warnings

    For external useonly

  • DO NOT USE

    Do not use

    • with a bandage
    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age
    • over extensive areas of the body
    • on irritated skin
  • WHEN USING

    When using this product

    • avoid contact with eyes or mucuos membranes
    • do not bandage
  • ASK DOCTOR

    Stop use and ask doctor if

    • conditions worsen or symptoms persists for more than 7 days
    •  symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to aviod accidental poisoning.

    If swallowed, induce vomiting and call a physician or contact a Poison Contol Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • use only as directed
    • adults and children 12 years or older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • store at 15° to 25° C (59° to 77° F)
  • INACTIVE INGREDIENT

    Inactive ingredients cajeput oil, clove oil, essential oil of peppermint, eucalyptus oil, juniper, menthol, white mineral oil.

  • QUESTIONS

    Questions?

    call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

  • PRINCIPAL DISPLAY PANEL

    La Flecha Japonsa Label

  • INGREDIENTS AND APPEARANCE
    LA FLECHA JAPONESA 
    methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE105 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CLOVE OIL (UNII: 578389D6D0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    MENTHOL (UNII: L7T10EIP3A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-047-011 in 1 CARTON
    115 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34802/21/2012
    Labeler - Menper Distributors, Inc. (101947166)

Related Drugs