Label: UNIDENTAL ALL CARETOOTHPASTE- sodium monofluorophosphate, cetylpyridinium chloride, potassium nitrate paste, dentifrice

  • NDC Code(s): 73669-012-01
  • Packager: Unimed Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 20, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Sodium monofluorophosphate, Cetylpyridinium chloride, Potassium nitrate

  • INACTIVE INGREDIENT

    Sodium benzoate, Glycerin, Glycyrrhizin acid, Sodium
    Copper Chlorophyllin, Sodium lauroyl sarcosinate, Menthol,
    Myrrh tincture, Amorphous sorbitol solution(70%),
    Saccharin sodium hydrate, Titanium dioxide, Sulfur, Sesin
    Ext., Sage Ext., Mugwort Ext., Ascorbic acid, Titrated Ext.
    of the unsaponifiable fraction of Zea mays L., Grapefruit
    Seed Ext., Xylitol, Purified water, Carboxymethyl Cellulose
    sodium, Chmomilla Extract, Bicarbonate sodium, Tocopheryl
    acetate, Polyethylene glycol 1500, Propolis Ext.,
    Pyrophosphate sodium, Pyridoxine Hydrochloride,
    Hydroxyapatite, TIXOSIL 43K, Fragrance

  • PURPOSE

    ■ Prevention and reduction of tooth pain
    ■ Protection of sensitive teeth (tooth pain)
    ■ Tooth decay prevention
    ■ Dental plaque removal (anti-plaque)
    ■ Prevention of gingivitis and periodontitis
    ■ Keeping teeth white and strong
    ■ Keeping the inside of the mouth clean
    ■ Aesthetic effect

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Brush your teeth with a suitable amount

  • WARNINGS

    ■ This toothpaste contains 1,000 ppm of fluoride
    ■ When used for children under the age of 6, use a very
    small amount of toothpaste while teaching them not to
    suck or swallow it
    ■ If a large amount is swallowed by a child under the age
    of 6, consult a doctor or a dentist immediately
    ■ Keep out of reach of children under the age of 6

  • DOSAGE & ADMINISTRATION

    dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    UNIDENTAL ALL CARETOOTHPASTE 
    sodium monofluorophosphate, cetylpyridinium chloride, potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73669-012
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE3.75 g  in 100 g
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73669-012-01100 g in 1 TUBE; Type 0: Not a Combination Product04/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/20/2023
    Labeler - Unimed Pharmaceuticals, Inc. (689852052)
    Registrant - Unimed Pharmaceuticals, Inc. (689852052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed Pharmaceuticals, Inc.689852052label(73669-012) , manufacture(73669-012) , pack(73669-012)