Label: THERACARE 5% MENTHOL PAIN RELIEF PATCH- menthol patch

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

Drug Label Information

Updated August 29, 2024

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 pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis ■ muscle strains ■ muscle sprains ■ bruises ■ cramps

  • WARNINGS

    For External Use Only.

  • 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 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 on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • 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.

  • Other Information

    Store at room temperature, not to exceed 86ºF (30ºC)

  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methacrylic ac d and ethyl acrylate copolymer, methylparaben, polysorbate 80, polyvinyl alcohol, povidone, propylparaben, sodium polyacrylate, sorb tan monooleate, sorb tol, tartaric acid, titanium dioxide, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    THERACARE 5% MENTHOL PAIN RELIEF PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TARTARIC ACID (UNII: W4888I119H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-053-055 in 1 BOX08/01/2024
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/01/2024
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences Private Ltd.872260479manufacture(71101-053)