Label: HEALTHWISE COLD THERAPY PAIN RELIEF PATCH- menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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

  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Use

    For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

  • Warnings

    For external use only

  • 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 consult a doctor if

    o condition worsens

    o redness is present

    o irritation develops

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

    o you experience signs of skin injury, such as 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

  • Directions

    Directions
    ■ Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove back ng starting at a corner. 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.

  • Other information

    Store at room temperature, not to exceed 86'F (30'C).

  • Inactive Ingredient

    aloe vera extract, arnica montana extract, boswellia carterii resin extract, carboxymethylcellulose sodium, ethylhexylglycerin, dihydroxyaluminum aminoacetate, glycerin, green tea extract, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • HealthWise Cold Therapy Pain Relief Patch

    label

  • INGREDIENTS AND APPEARANCE
    HEALTHWISE COLD THERAPY PAIN RELIEF PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-950
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    POVIDONE (UNII: FZ989GH94E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-950-1515 in 1 CARTON12/01/2023
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2023
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.529128763manufacture(71101-950)