WINCO EXTRA STRENGTH COLD AND HOT MEDICATED (MENTHOL) PATCH [WINCO FOODS, LLC]

WINCO EXTRA STRENGTH COLD AND HOT MEDICATED (MENTHOL) PATCH [WINCO FOODS, LLC]
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NDC 67091-275-05
Set ID 78d3f786-99f8-4bcf-936d-9e5119568201
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient (in each patch)                                                                                     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
    • sumptoms 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 righta way

  • INDICATIONS & USAGE

    Directions

    adults and children 12 years of age and older:

    • peel off protective backign 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

    1,3-butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disodium edetate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminium hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WINCO FOODS, LLC

    BOISE, ID 83704

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WINCO EXTRA STRENGTH COLD AND HOT MEDICATED 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-275
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBITOL (UNII: 506T60A25R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MAGALDRATE (UNII: 6V88E24N5T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-275-055 in 1 BOX02/07/2017
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/16/2015
    Labeler - WinCo Foods, LLC (056098817)

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