Label: SELLA NATURAL- menthol paste, dentifrice

  • 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 February 11, 2015

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  • ACTIVE INGREDIENT

    MENTHOL


  • INACTIVE INGREDIENT

    sorbitol, glycerin, stevioside, xylitol, alcohol, etc


  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply toothpaste on soft bristle toothbrush
    brush thoroughly after each meal


  • WARNINGS

    if irritation occurs discontinue use


  • DOSAGE & ADMINISTRATION

    for oral use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    SELLA NATURAL 
    menthol paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69603-1401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69603-1401-1100 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/01/2014
    Labeler - Sella Natural Cosmetics Co.,Ltd. (687563333)
    Registrant - Sella Natural Cosmetics Co.,Ltd. (687563333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sella Natural Cosmetics Co.,Ltd.687563333manufacture(69603-1401)