Label: AMAZON BASICS PAIN RELIEF PATCH WITH 4% LIDOCAINE- lidocaine patch

  • NDC Code(s): 72288-967-15
  • Packager: Amazon.com Services LLC
  • 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 January 4, 2023

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  • Active Ingredient

    Lidocaine 4.0%

  • Purpose

    Topical anesthetic

  • Use

    Temporarily relieves minor pain.

  • Warnings

    For external use only

    Do not Use

    ■ More than one patch on your body at a time■ On cut. irritated or swollen skin■ On puncture wounds

    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 lightly 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

    ■ 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. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use. Children under 12 years of age: consult a physician.

  • 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

  • Amazon Basics Pain Relief Patch with 4% Lidocaine, 15 ct

    label

  • INGREDIENTS AND APPEARANCE
    AMAZON BASICS PAIN RELIEF PATCH WITH 4% LIDOCAINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-967
    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)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TARTARIC ACID (UNII: W4888I119H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    POVIDONE (UNII: FZ989GH94E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-967-1515 in 1 CARTON01/01/2023
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2023
    Labeler - Amazon.com Services LLC (128990418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.529128763manufacture(72288-967)
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