Label: EASY- menthol patch

  • 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 February 16, 2012

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  • 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:66897-002
    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:66897-002-055 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2012
    Labeler - Wicsun Trading (960476174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wong’s Pharmaceutical International Ltd.667304257manufacture
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