Label: MAXIMUM STRENGHT LIDOCAINE PLUS MENTHOL PAIN RELIEF PATCH- lidocaine, menthol 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 April 15, 2021

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

  • Active Ingredients

    Lidocaine 4.0% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

    Menthol 1.0% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

  • 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 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

    ■ 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.

  • PREGNANCY OR BREAST FEEDING

    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 800-222-1222 right away.

  • Dosage and Administration

    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 Safety Information

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

  • Inactive Ingredients

    Carboxymethylcellulose sodium, Dihydroxyaluminum Aminoacetate, 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

  • Uses

    Temporarily relieves minor pain.

  • Uses

    Temporarily relieves minor pain.

  • Maximum Strenght Lidocaine plus Menthol Pain Relief Patch

    label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGHT LIDOCAINE PLUS MENTHOL PAIN RELIEF PATCH 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6514
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6514-15 in 1 CARTON03/01/2021
    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 finalpart34803/01/2021
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech529128763manufacture(11822-6514)