Label: SIGNATURE CARE MEDICATED PAIN RELIEF PATCH- lidocaine patch

  • NDC Code(s): 21130-988-01, 21130-988-05
  • Packager: Safeway, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2025

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  • Active Ingredient

    Lidocaine

  • Purpose

    Topical anesthetic

  • Use

    For temporary relief of pain

  • Warning

    For external use

    Do not use

    ■ More than one patch on your body at a time ■On cut, irritated or swollen skin ■On puncture wounds ■Over raw surfaces or blistered areas ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients■ If pouch is damaged or opened.

    When using this product

    ■Use only as directed■Read and follow all directions and warnings on this carton ■Do not allow contact with the eyes ■Do not use at the same time as other topical analgesics ■Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■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 consult 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 breastfeeding

    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 (1-800-222-1222) right away.

  • Directions

    ■Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use ■Children under 12 years of age: consult a physician.

  • Other information

    Other information
    Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

  • Inactive ingredients


    aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE MEDICATED PAIN RELIEF PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-988
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-988-055 in 1 CARTON01/01/2025
    19 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:21130-988-011 in 1 POUCH01/01/2025
    29 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2025
    Labeler - Safeway, Inc. (009137209)
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