Label: SOLCURE THERA ROLL HOT PRO- menthol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 1, 2023

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  • ACTIVE INGREDIENT

    menthol

  • INACTIVE INGREDIENT

    Water
    Ethanol
    Chamaecyparis Obtusa Water
    Dipropylene Glycol
    Glycerin
    Illite Extract
    Butylene Glycol
    Vincetoxicum Atratum Extract
    Sodium Polyacrylate
    Laureth-7
    C13-14 Isoalkane
    Vanillyl Butyl Ether
    Fragrance

  • PURPOSE

    therapy by warming & relaxing

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children

  • INDICATIONS & USAGE

    Apply an appropriate amount as if massaging before and after exercise (except for the face and sensitive body parts)

  • WARNINGS

    This product is for exeternal use only. Do not use for internal use
    Storage and handling precautions
    If possible, avoid direct sunlight and store in cool and area of low humidity in order to maintain the quality of the product and avoid misuse
    Avoid placing the product near fire and store out in reach of children

    - consult a physician in case of abnormal symptoms, such as red spots, swelling or itching, or side effects in the areas of application due to direct light during or after using the product

    - do not use on wounded area

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SOLCURE THERA ROLL HOT PRO 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83235-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83235-0002-180 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2023
    Labeler - Erae Natural Life (695930484)
    Registrant - Erae Natural Life (695930484)
    Establishment
    NameAddressID/FEIBusiness Operations
    Erae Natural Life695930484manufacture(83235-0002)
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