Label: THERA CARE COLD HOT MEDICATED PATCH- 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 January 11, 2023

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

  • ACTIVE INGREDIENT

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

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

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Temporarily relieves minor aches and pains of muscles and joints: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis

    ■ muscle strains ■ muscle sprains ■ bruises ■ 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 a 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 ■ redness is present ■ If 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.

  • If pregnant or breastfeeding

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

    Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. 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 86F (30C)

  • INACTIVE INGREDIENT

    Acrylates Copolymer, Alcohol, Carboxymethylcellulose sodium, Edetate Disodium, Dihydroxyaluminium amino acetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Polyvinyl alcohol, Propylparaben, PVP, Sodium Polyacrylate, Sorbitan oleate, Sorbitol, Tartaric Acid, Titanium Dioxide Water

  • PRINCIPAL DISPLAY PANEL

    Packlabel

  • INGREDIENTS AND APPEARANCE
    THERA CARE COLD HOT MEDICATED PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-954
    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
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
    ALCOHOL (UNII: 3K9958V90M)  
    ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (UNII: E5024Y9FFQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBITOL (UNII: 506T60A25R)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-954-055 in 1 BOX10/01/2020
    19 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2020
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences, Private Limited872260479manufacture(71101-954)