PURE-AID (LIDOCAINE, MENTHOL) PATCH [KAREWAY PRODUCT, INC.]

PURE-AID (LIDOCAINE, MENTHOL) PATCH [KAREWAY PRODUCT, INC.]
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NDC 67510-0284-1
Set ID 6679cada-f083-26e8-e053-2a91aa0adcc5
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active ingredient

    Lidocaine 4%

    Menthol 1%

  • Purposes

    Topical Anesthetic

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only

  • Do Not Use

    • more than 1 patch on your body at a time or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor
  • When Using This Product

    • use only as directed. Read and follow all directions and warnings on this label.
    • rare cases of serious burns have been reported with products of this type
    • do not apply to wounds or damaged, broken or irritated skin
    • do not allow contact with the eyes and mucous membranes
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • do not use at the same time as other topical analgesics
    • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
  • Stop Use and Ask a Doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
  • If Pregnant or Breast-Feeding

    ask a health professional before use.

  • Keep Out of Reach of Children and Pets

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

  • Directions

    adults and children over 12 years:

    • clean and dry affected area
    • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
    • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
    • use 2 patch for up to 24 hours

    children 12 years or younger: ask a doctor

  • Inactive Ingredients

    dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid,

    propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

  • Package/Label Principal Display Panel

    Pure-Aid

    MAXIMUM STRENGTH

    LIDOCAINE PATCH
    PLUS MENTHOL

    Targeted Immediate Pain Relief

    • Desensitizes Aggravated Nerves
    • Dual Action with Lidocaine and Menthol
    • Fast Acting and Long Lasting
    • First Aid for Pain

    Pain Relieving Ointment
    on a Breathable Adhesive Pad

    Contains 1 Patch

    3-15/16” x 5-1/2” (10 cm x 14 cm) each

    Label

    pouch

  • INGREDIENTS AND APPEARANCE
    PURE-AID 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0284
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE240 mg
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM60 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0284-11 in 1 POUCH; Type 0: Not a Combination Product03/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/02/2018
    Labeler - Kareway Product, Inc. (121840057)

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