Label: FRESHMAX FLUORIDE MINTY FLAVOR- sodium monofluorophosphate paste

  • NDC Code(s): 52862-501-00
  • Packager: International Wholesale Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • Drug Facts

  • Active Ingredient

    Sodium Monofluorophosphate 0.76%

    (Available fluoride content:1000ppm)

    Purpose

    Anticavity

  • Uses

    Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities.

  • Warnings

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

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age to use a pea size amount. Supervise child’s brushing and rinsing (to minimize swallowing.) Consult a dentist or physician. Adults and children 2 years of age or older:Children under 6 years:Children under 2 years of age:

  • Inactive Ingredients

    Water, Sorbitol, Polyethylene Glycol 400, Sodium Carboxymethylcellulose, Silica, Gypsum Powder, Sodium Saccharin, Sodium Lauryl Alcohol, Flavor, Methyl Paraben, Propylparaben, Color: Bright Blue.

  • Other Information:

    Lot No. & Expiration Date: See box or crimp of tube.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    FRESHMAX FLUORIDE MINTY FLAVOR 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-501
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION76 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-501-001 in 1 BOX02/27/2017
    1181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/27/2017
    Labeler - International Wholesale Inc (161872676)
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