Label: PAIN RELIEF THERAPY PATCH- menthol patch

  • Category: HUMAN OTC DRUG LABEL

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 January 31, 2013

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  • ACTIVE INGREDIENT

    Active ingredient                                                               Purpose

    Menthol 5% .....................................................................Topical analgesic

  • PURPOSE

    Uses temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • muscle sprains
    • bruises
    • cramps
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product:

    • use only as directed
    • do not bandage tightly or use with heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin
  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
  • 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.  If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    adults and children 12 years of age and older:

    • peel off protective backing and apply sticky side to affected area
    • carefully remove backing from patch
    • should be used up to 8 hours
    • should be used no more than 3 times a day
    children under 12 years of age:
    • consult a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients: Aloe Barbadensis Leaf Juice, Aluminum Hydroxide, Disodium EDTA, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium Dioxide, Isopropyl Myristate, Purified Water,

    Polyvinyl Pyrrolidone, Peg-4 Stearate, Polyvinyl Alcohol, Polysorbate 80, PVP, Tocopherol Acetate, Alumino Magnesium Metasilicate, Castor Oil, Tartaric Acid, BHT, Sodium Polyacrylate.

  • DOSAGE & ADMINISTRATION

    Distributed by:

    UNITED EXCHANGE CORP

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF THERAPY PATCH  
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-700-055 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/31/2013
    Labeler - UNITED EXCHANGE CORP (840130579)
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