Label: TIDL PAIN RELIEF NUMBING PATCH- pain relief patch patch

  • NDC Code(s): 83822-003-01
  • Packager: Fuzhou Ayimong Trading Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 23, 2024

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

  • Active Ingredient

    Lidocaine 4%
    Menthol 3%

  • Purpose

    Topical anesthetic

  • Use

    for the temporary relief of pain

  • Warnings

    For external use only

  • Do not use

    ·on puncture wounds,cuts,irritated,damaged or swollwn skin

    ·more than 1 patch on your body at a time or with other topical analgesics at the same time

    ·with a heating pad or apply local heat to the area of use

  • When Using

    ·use only as directed

    ·do not bandage tightly

    ·avoid contact with eyes and mucous membranes

    ·rare cases of serious burns have been reported with products of this type

    ·a transient burning sensation may occur upon application but generally disappears in several days

    ·dispose of used patch in manner that always keeps products 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

    ·condition worsens or symptoms persist for more than 7 days
    ·symptoms clear up and occur again within a few days
    ·severe burning sensation,redness or irritation develops
    ·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied

  • Ask Doctor

    ·condition worsens or symptoms persist for more than 7 days
    ·symptoms clear up and occur again within a few days
    ·severe burning sensation,redness or irritation develops
    ·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied

  • Keep Oot Of Reach Of Children

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Adults and children 12 years of age and older:
    -clean and dry affected area
    -remove backing from patch by firmly grasping both ends and gently pulling until backing seprarates in middle
    -carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
    -once exposed portion of the patch is positioned,carefully remove remaining backing to completely apply patch
    to affected area - use 1 patch at a time and not more than 3 to 4 times daily
    Children under 12 years of age: consult a doctor

  • Inactive ingredients

    Aluminum glycinate, chili extract, EDTA-2NA, ethanol, glycerol, sodium polyacrylate, tartaric acid,
    water, wintergreen oil

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    TIDL PAIN RELIEF NUMBING PATCH 
    pain relief patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83822-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    TARTARIC ACID (UNII: W4888I119H)  
    ALCOHOL (UNII: 3K9958V90M)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPSICUM (UNII: 00UK7646FG)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83822-003-0120 in 1 BOX; Type 0: Not a Combination Product03/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/24/2024
    Labeler - Fuzhou Ayimong Trading Co., Ltd. (416068159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fuzhou Ayimong Trading Co., Ltd.416068159label(83822-003) , manufacture(83822-003)