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 65923-701-05
Set ID e024aaaf-f615-4b7a-99af-cbdafd05c420
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 Temporary relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • 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 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 vera, aluminum hydroxide, BHT, caster oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, 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:65923-701
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    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:65923-701-055 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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