EASY (MENTHOL) PATCH [WONG’S PHARMACEUTICAL INTERNATIONAL]

EASY (MENTHOL) PATCH [WONG’S PHARMACEUTICAL INTERNATIONAL]
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NDC 11446-188-05
Set ID ecdb2270-d247-4fc4-92d1-f9cf78129085
Category HUMAN OTC DRUG LABEL
Packager Wong’s Pharmaceutical International
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Menthol 4%

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of minor pains and aches of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
  • Warnings

    • For external use only
    • Avoid getting into the eyes or on mucus 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

    • 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
  • 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 avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children2 years of age and older. Apply to affected area not more than 3-4 times daily.

    Children under 2 years of age: Do not use, consult a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients Sesame Oil, Terebinthina resin, Zinc Oxide and Methyl salicylate

  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    EASY  
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11446-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol4 g
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    SCHINUS TEREBINTHIFOLIUS WHOLE (UNII: X6763LQ3TQ)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11446-188-055 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2012
    Labeler - Wong’s Pharmaceutical International (667304257)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wong’s Pharmaceutical International Ltd.667304257manufacture

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