Label: DR SABHARWALS- lidocaine 4% and menthol 1% patch patch

  • NDC Code(s): 71318-115-15
  • Packager: Dr. Sabharwal's Wound Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

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

  • ACTIVE INGREDIENT

    Lidocaine 4%

    Menthol 1%

  • PURPOSE

    Topical Anesthetic

  • INTENDED USE OF THE DEVICE

    Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

  • WARNINGS

    For external use only

  • DO NOT USE

    • more than 1 patch on your body at a time or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor
  • WHEN USING

    • use only as directed. Read and follow all directions and warnings on this label.
    • do not allow contact with the eyes
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • do not use at the same time as other topical analgesics
    • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
  • ASK 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

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Adults and children over 12 years:

    • clean and dry affected area
    • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
    • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
    • use 1 patch for up to 12 hours

    children 12 years or younger:

    • ask a doctor
  • INACTIVE INGREDIENT

    Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

  • QUESTIONS

    Call +91-905-677-0088

  • DOSAGE & ADMINISTRATION

    Topical Patch for external use only

  • INDICATIONS & USAGE

    Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

  • PRINCIPAL DISPLAY PANEL

    Lidocaine 4% Menthol 1% Patch

  • INGREDIENTS AND APPEARANCE
    DR SABHARWALS 
    lidocaine 4% and menthol 1% patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71318-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE224 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL56 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SORBITOL (UNII: 506T60A25R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71318-115-1515 in 1 CARTON01/30/2024
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/30/2024
    Labeler - Dr. Sabharwal's Wound Care (862184668)
    Registrant - Dr. Sabharwal's Wound Care (862184668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Sabharwal's Wound Care862184668manufacture(71318-115)