Label: HEALTHWISE MEDICATED COLD HOT 5% PATCH- menthol patch

  • NDC Code(s): 71101-031-06, 71101-031-25
  • Packager: Veridian Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 17, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredient ...............................................................................................Purpose

    Menthol 5%...............................................................................................Topical Analgesic

  • INACTIVE INGREDIENT

    carboxymethylcellulose sodium, Dihydroxyaluminum Aminoacetate, Glycerin, iodopropynyl butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol

  • KEEP OUT OF REACH OF CHILDREN

    Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • INDICATIONS & USAGE

    Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis

    ■ muscle strains ■ muscle sprains ■ bruises ■ cramps

  • WARNINGS

    For External Use Only.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

    Children under 12 years of age: consult a physician.


  • PURPOSE

    Topical Analgesic

  • When using this product

    When using this product

    ■ Use only as directed

    ■ Rare cases of serious burns have been reported with products of this type

    ■Don't bandage tightly or use with heating pad

    ■ Avoid contact with eyes and mucous membranes

    ■ Don't apply to wounds or damaged skin

    ■ Do not use at the same time as other topical analgesics.

  • Stop use and ask a doctor

    If condition worsens ■ If redness is present ■ If irritation develops

    ■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

    ■ You experience signs injury, such a s pain, swelling, or blistering where the product was applied.

  • If pregnant or breastfeeding

    ask a health professional before use.

  • PRINCIPAL DISPLAY PANEL

    Packlabel

  • INGREDIENTS AND APPEARANCE
    HEALTHWISE MEDICATED COLD HOT 5% PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TARTARIC ACID (UNII: W4888I119H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-031-066 in 1 BOX04/01/2024
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:71101-031-2525 in 1 BOX04/01/2024
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2024
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(71101-031)