Label: CLEANAFNATURALANTICAVITYTOOTHPASTE- sodium fluroide paste, dentrifice paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 14, 2017

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  • PRINCIPAL DISPLAY PANEL

    Toothpaste

    Sodium Fluoride 0.22% (0.10% w/v fluoride ion)

    Hydrated Silica, sodium benzoate, sodium lauryl sulfate, water, flavor, sorbitol, CMC, xantham gum, sodium phytate, sodium saccharin, titanium dioxide, glycerin​

    Anticavity

    Do not swallow

  • INGREDIENTS AND APPEARANCE
    CLEANAFNATURALANTICAVITYTOOTHPASTE 
    sodium fluroide paste, dentrifice paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71603-1700
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71603-1700-0142 g in 1 TUBE; Type 0: Not a Combination Product07/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/17/2017
    Labeler - CLEANAF GLOBAL LIMITED LIABILITY COMPANY (080739804)
    Registrant - CLEANAF GLOBAL LIMITED LIABILITY COMPANY (080739804)
    Establishment
    NameAddressID/FEIBusiness Operations
    CLEANAF GLOBAL LIMITED LIABILITY COMPANY080739804label(71603-1700)
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