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Regular (Kareway Product, Inc.)

Available Formats

Dosage Form Package Information Links
PASTE, DENTIFRICE 1 TUBE in 1 BOX (67510-0012-4) > 181 g in 1 TUBE Label Information

Complete Regular Information

  • Active ingredient

    Sodium Monofluorophosphate 0.76% (0.15%w/v fluoride ion)


  • Purpose

    Anticavity
  • Usage

    helps protect against cavities


  • Warnings

    Enter section text here

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    Adults and children 2 years of age and older
    brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    Children 2 to 6 years
    use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
    Children under 2 years
    ask a dentist or physician

  • Inactive ingredients

    calcium carbonate, sorbitol, water, silicon dioxide, glycerine, sodium lauryl sulfate, sodium carboxymethyl cellulose, methyl parahydroxybenzoate, aminocaproic acid, xylitol, sodium saccharin, DL-menthol, flavor


  • PRINCIPAL DISPLAY PANEL

    Enter section text hereimage of toothpaste carton


  • INGREDIENTS AND APPEARANCE
    REGULAR 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0012
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.76 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMINOCAPROIC ACID (UNII: U6F3787206)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MENTHOL (UNII: L7T10EIP3A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0012-4 1 in 1 BOX
    1 181 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 08/15/2011
    Labeler - Kareway Product, Inc. (121840057)