Label: POINT RELIEF LIDOSPOT- 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 5, 2022

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

  • Active ingredient

    Lidocaine 4.0% w/w ...... Purpose: Topical anesthetic

    Menthol 1.0% w/w ...... Purpose: Topical analgesic

  • Purposes

    Topical anesthetic (Lidocaine)

    Topical analgesic (Menthol)

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only

  • 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 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.
  • 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.
  • Stop use and consult a doctor if

    • Condition worsen
    • 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 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 right away.

  • Directions

    Adult and Children 12 years of age and over:

    Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply stickly side of patch to affected area. Use one patch for up to 12 hours.

    Children under 12 years of age: Consult a physician.

  • Inactive ingredients

    Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide, Polysorbate 80, Mineral Oil, Propylene Glycol, L(+)-Tartaric Acid, Polyacrylic Acid, PolyvinylPyrrolidone K90, Hydroxyacetophenone, Water

  • Other information

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

  • Package label. Principal display panel

    0105

  • INGREDIENTS AND APPEARANCE
    POINT RELIEF LIDOSPOT 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 3 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.12 g  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51452-173-055 in 1 POUCH04/05/2022
    1NDC:51452-173-013 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 finalpart34804/05/2022
    Labeler - Fabrication Enterprises (070577218)
    Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(51452-173)