Label: PURE-AID- lidocaine, menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 30, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient

    Lidocaine 4%

  • Purposes

    Topical Anesthetic

  • 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

    Label

    pouch

  • INGREDIENTS AND APPEARANCE
    PURE-AID 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0280
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE240 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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 (8000 MW) (UNII: 73861X4K5F)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POVIDONE (UNII: FZ989GH94E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0280-11 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)