Label: MINT- sodium monofluorophosphate paste, dentifrice

  • 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 February 2, 2012

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  • 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
    MINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0011
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0011-41 in 1 BOX
    1181 g in 1 TUBE
    2NDC:67510-0011-61 in 1 BOX
    2170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/15/2011
    Labeler - Kareway Product, Inc. (121840057)
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