Label: CAREONE LIDOCAINE PAIN RELIEF- lidocaine patch

  • NDC Code(s): 41520-789-91
  • Packager: American Sales Company
  • 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 July 10, 2020

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  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

    For 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 have ever had an allergic reaction to this product or any of its ingredients

    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

    •
    localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    •
    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.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    Adults and children 12 years of age and over:

    •
    clean and dry affected area
    •
    remove film from patch and apply to the skin (see illustration)
    •
    apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    •
    remove patch from the skin after at most 8 hours of application

    Children under 12 years of age: consult a doctor

  • Other information

    •
    avoid storing product in direct sunlight
    •
    protect product from excessive moisture
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, tartaric acid, urea

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to the active ingredient in Salonpas® Lidocaine Patch

    MAXIMUM STRENGTH

    LIDOCAINE PAIN RELIEF PATCHES

    4% Lidocaine/Topical Anesthetic

    Desensitizes Aggravated Nerves

    UP TO 8 HOURS NUMBING RELIEF

    UNSCENTED

    OUR PHARAMCIST RECOMMEND

    6 PATCHES

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

    lidocaine patch image 1
    lidocaine patch image 2
  • INGREDIENTS AND APPEARANCE
    CAREONE LIDOCAINE PAIN RELIEF 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-789
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE560 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TARTARIC ACID (UNII: W4888I119H)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-789-916 in 1 CARTON07/09/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/09/2020
    Labeler - American Sales Company (809183973)
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