Label: PUREGEN LABS PAIN RELIEF 4 LIDOCAINE- lidocaine patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 11, 2024

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  • Drug Facts

  • Active ingredient

    Lidocaine 4.00 %

    Purpose

    Topical Anesthetic

  • Uses:

    • For the temporary relief of pain.
  • Warnings:

    For external use only.

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • If you are allergic to any ingredients of this product

    When using this product

    • Avoid contact with the eyes

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation
    • condition worsens, or if
    • symptoms persist for more than 7 days or 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.

    If pregnant or breast-feeding,

    ask a health professional before use

  • Directions:

    • Adults andchildren 12 years of age and older:
    • Clean and dry the affected area
    • Apply a patch at a time to the affected area; not more than 3 or 4 times daily to the affected area
    • Remove the patch from the skin after at most 8 hours of application
    • Children under 12 years of age: consult a doctor.
  • Other information:

    • Store at 20-25°C (68-77°F) and protect from moisture.
  • Inactive ingredients

    Aqua (Deionized Water), Dihydroxyaluminum Aminoacetate, Disodium EDTA, Glycerin, Methylparaben, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

  • Questions?

    call toll-free 1-800-630-8895

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PUREGEN LABS PAIN RELIEF 4 LIDOCAINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-814
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-814-3030 in 1 BOX06/03/2024
    112 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/03/2024
    Labeler - Advanced Rx LLC (042795108)
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