Label: EQUATE LIDOCAINE COOL AND HEAT- lidocaine 4% plus menthol 1% 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 January 25, 2021

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  • ACTIVE INGREDIENT

    Lidocaine 4.0%
    Menthol 1.0%

  • PURPOSE

    Topical Anesthetic
    Topical Anesthetic

  • Uses

    Temporarily relieves minor pain

  • - Warnings



    For external use only.

    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 the used patch in a 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.

    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

    Stop and ask 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 ( 1800-222-1222) right away

  • Directions

    Adults and children 12 years of age and over: Clean and the dry affected area. Carefully remove backing from the patch starting at a corner. Apply the sticky side of patch to the affected area. Use one patch for up to 12 hours. Discard patch after a single use. Children under 12 years old of age: consult a physician.

  • OTHER SAFETY INFORMATION

    Store in a clean, dry place outside of direct sunlight. Protect for excessive moisture.

  • INACTIVE INGREDIENT

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

  • Equate Lidocaine + Menthol Pain Relief Patch

    label

  • INGREDIENTS AND APPEARANCE
    EQUATE LIDOCAINE COOL AND HEAT 
    lidocaine 4% plus menthol 1% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-038-055 in 1 BOX01/01/2021
    16 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2021
    Labeler - Walmart Stores Inc (051957769)
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