PURE-AID (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [KAREWAY PRODUCT, INC.]

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  • PURE-AID (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [KAREWAY PRODUCT, INC.]

PURE-AID (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [KAREWAY PRODUCT, INC.]
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NDC 67510-0289-1, 67510-0289-2
Set ID 6def9da7-e118-fd5c-e053-2991aa0a65d2
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredients

    Camphor 3.1%

    Menthol 6.0%

    Methyl salicylate 10.0%

  • Purpose

    Topical analgesic

  • Uses

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

    • arthritis
    • simple backache
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Allergy alert:

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    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

    If pregnant or breast-feeding,

    ask a health professional before use.

    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
    • remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

  • Other information

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

    Hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

  • Principal Display Panel

    Pure-aid Pain Relief Patch

    carton

  • INGREDIENTS AND APPEARANCE
    PURE-AID 
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0289
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)21.56 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL41.73 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE69.55 mg
    Inactive Ingredients
    Ingredient NameStrength
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0289-11 in 1 BOX06/05/2018
    110 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67510-0289-21 in 1 BOX06/05/2018
    220 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/05/2018
    Labeler - Kareway Product, Inc. (121840057)
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