Label: DR SABHARWALS- menthol 5% patch patch

  • NDC Code(s): 71318-116-15
  • 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

    Menthol 5%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache, arthritis, strains, bruises and sprains

  • WARNINGS

    For external use only

  • DO NOT USE

    • more than 1 patch on your body at a time
    • on cut, irritated or swollen skin
    • on puncture wounds or damaged skin
    • for more than one week without consulting a doctor
    • with heating pad
    • on a child under 12 yeas of age with arthritis-like conditions
  • WHEN USING

    • use only as directed.
    • read and follow all directions and warnings on this label
    • rare cases of serious burns have been reported with products of this type.
    • do not apply to wounds or damaged, broken or irritated skin
    • do not allow contact with eyes and mucous membranes
    • 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 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
    • a transient burning sensation may occur upon application but generally disappears in several days
    • if a severe burning sensation occurs, discontinue use immediately.
    • discontinue use at least 1 hour before a bath or shower.
    • do not use immediately after a bath or shower.
  • ASK DOCTOR

    • condition worsens
    • redness is present over the affected area
    • excess skin irritation occurs
    • 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 pregnanat or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children and pets

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

  • INSTRUCTIONS FOR USE

    Adult and children over 12years:

    • Clean and dry affected area
    • remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle
    • carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
    • do not wear a patch for more than 8 hours
    • apply affected area no more than 3 times daily

    children 12 years or younger:

    • ask a doctor
  • STORAGE AND HANDLING

    Store at room temperature 20-25 0C (68-77 0F)

  • QUESTIONS

    Call +91-905-677-0088

  • 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.

  • DOSAGE & ADMINISTRATION

    Topical Pain Relief Patch of External Use Only

  • PRINCIPAL DISPLAY PANEL

    Menthol 5% Patch

  • INGREDIENTS AND APPEARANCE
    DR SABHARWALS 
    menthol 5% patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71318-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL240 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TARTARIC ACID (UNII: W4888I119H)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71318-116-1515 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(71318-116)