PAIN RELIEF (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE PATCH) PATCH [KAREWAY PRODUCT, INC.]

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  • PAIN RELIEF (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE PATCH) PATCH [KAREWAY PRODUCT, INC.]

PAIN RELIEF (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE PATCH) PATCH [KAREWAY PRODUCT, INC.]
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NDC 67510-0305-2
Set ID d3ede306-9ef7-4a89-896b-c083f6e43c85
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredient

    DL-Camphor 1.2%

    L-Menthol 5.7%

    Methyl Salicylate 6.3%

  • Purpose

    Topical Analgesic

    Topical Analgesic

    Topical Analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

    • arthritis
    • simple backaches
    • strains
    • bruises
    • sprains
  • Warnings

    for external use only

    Do not use

    • on wounds or damaged skin
    • if you are allergic to aspirin or salicylates
    • with a heating pad
    • with, or at the same time as, other external analgesic products

    Ask a doctor before use,

    if you are allergic to any ingredients of this product.

    When using this product

    • use only as directed
    • avoid contact with eyes, mucous membranes or rashes

    Stop use and ask a doctor if

    • rash, itching or excessive skin irritation develops
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and over:

    • clean and dry affected area
    • remove patch from film
    • apply to affected area not more than 3 to 4 times daily for 7 days
    • wear up to 8 hours per application

    Children under 12 years of age:

    • consult a doctor
  • Other information

    • avoid storing product in direct sunlight
    • protect from excessive moisture
  • Inactive ingredients

    butylated hydroxytoluene, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, quintone, sorbitan stearate, tocopherol acetate, ys resin, zinc oxide

  • Carton label

    Pain Relief Patch image of carton label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    dl-camphor, l-menthol, methyl salicylate patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.4 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL1.8 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0305-220 in 1 CARTON01/25/2012
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/25/2012
    Labeler - Kareway Product, Inc. (121840057)
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