Label: DR TICHENORS WITH EXTRA WHITENING AND TARTAR CONTROL- sodium fluoride paste, dentifrice

  • NDC Code(s): 11291-243-01, 11291-243-02
  • Packager: Dr. G. H. Tichenor's Antiseptic Company
  • 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 November 7, 2019

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  • Active Ingredients

    Sodium Fluoride USP 0.243% w/w

  • Purpose

    Anticavity toothpaste

  • Uses

    Aids in the prevention of dental cavities.

  • Warnings

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center right away.

  • Directions

    • Adults and children two years of age and older: brush teeth thoroughly, preferably after every meal or at least twice a day, or as directed by a dentist or physician.
    • Instruct children under six years of age on good brushing and rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision.
    • Children under two years of age: Consult a dentist or physician.
  • Inactive Ingredients

    water, sorbitol, hydrated silica, glycerin, tetrapotassium pyrophosphate, cellulose gum, flavor, titanium dioxide, sodium lauryl sulfate, papain, sodium saccharin

  • ​Questions? Comments?

    Visit our website at www.drtichenor.com

  • Image of Outer Carton and Tube Label

    DrTichenorToothpasteCarton.jpg Carton DrTichenorTootpasteTubeLabel.jpg Label

  • INGREDIENTS AND APPEARANCE
    DR TICHENORS WITH EXTRA WHITENING AND TARTAR CONTROL 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11291-243
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PAPAIN (UNII: A236A06Y32)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11291-243-021 in 1 CARTON10/24/2012
    1NDC:11291-243-01181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/24/2012
    Labeler - Dr. G. H. Tichenor's Antiseptic Company (008161556)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. G. H. Tichenor's Antiseptic Company008161556manufacture(11291-243)
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