Label: ALBERTSON LIDOCAINE, MENTHOL PAIN RELIEF MEDICATED PATCH- lidocaine and 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 11, 2022

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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

    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-(2ethylhexyloxy)propane-1,2-diol.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALBERTSON LIDOCAINE, MENTHOL PAIN RELIEF MEDICATED PATCH 
    lidocaine and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-961
    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
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-961-055 g in 1 CARTON; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2022
    Labeler - Safeway (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(21130-961)
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