EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]

EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]
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NDC 65923-702-03
Set ID f7e1c664-3366-437d-851d-cd9bcd532d41
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp
Generic Name
Product Class
Product Number
Application Number PART348
  • 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 a 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
  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • 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
  • STORAGE AND HANDLING

    Other information

    • store at room temperature, not to exceed 86°F (30°C)
  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadenisis leaf juice, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminate metasilicate, methyl paraben, peg-40 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate, Release Liner: polypropylene, Non-Woven Material: Polyester Non-Woven Fabric.

  • 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
    EXTRA STRENGTH PAIN RELIEF THERAPY 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-702
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-702-033 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2013
    Labeler - United Exchange Corp (840130579)

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