Label: BASIC CARE LIDOCAINE- lidocaine 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 September 30, 2019

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

  • 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.

  • Keep out of reach of children.

    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 Salonpas® Lidocaine Patch active ingredient

    Maximum Strength

    lidocaine patch

    4% Lidocaine

    Topical Anesthetic

    Numbing Relief

    Up to 8 hours of relief

    Unscented

    Desensitizes Aggravated Nerves

    For temporary relief of pain

    Back

    Neck

    Shoulders

    Knees & Elbows

    6 PATCHES 3 – 15/16” x 5 – 1/2” (10 cm x 14 cm)

    7u2-an-lidocaine-patch.jpg
  • INGREDIENTS AND APPEARANCE
    BASIC CARE LIDOCAINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-7700
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE560 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    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:0113-7700-916 in 1 CARTON09/25/2019
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/25/2019
    Labeler - L. Perrigo Company (006013346)