Label: THERACARE PAIN RELIEF MEDICATED- lidocaine and menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active ingredients

    Lidocaine 4%

    Menthol 1%

  • Purposes

    Topical anesthetic

    Topical analgesic

  • Use

    for the temporary relief minor pain

  • Warnings

    For external use only

    Do not use

    ■ more than 1 patch on your body at a time

    ■ on a 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 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 ask 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 pain, swelling, or blistering where the product was applied

    If pregnant or breast-feeding,

    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 800-222-1222 right away.

  • Directions

    adults and children 12 years of age and older:

    ■ clean and dry affected area

    ■ Carefully remove backing from patch starting at a corner

    ■ Apply sticky side of patch to affected area

    ■ use 1 patch for up to 12 hours

    ■ Discard patch after single use

    children under 12 years of age: consult a physician

  • Inactive ingredients

    aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • TheraCare Pain Relief Medicated

    label

  • INGREDIENTS AND APPEARANCE
    THERACARE PAIN RELIEF MEDICATED 
    lidocaine and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-912
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-912-055 g in 1 CARTON; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2023
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(71101-912)
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