Label: ORAPRO FLUORIDE ANTICAVITY- fluoride toothpaste paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 10, 2025

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  • Drug Facts 

  • Active ingredient

    Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

  • Purpose 

    Anticavity

  • Use

    Helps protect agaisnt cavities

  • Warnings 

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

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

  • 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 habits (to minimize swallowing). Supervise children as nessary until capable of using without supervision. Children under 2 years ask a dentist or physician

  • Inactive ingredients:

     Glycerol, Water, Hydrated Silica, Crystalline Cellulose, Cellulose, Flavor, Cocamidopropyl Betaine, Sodium Gluconate, Carbomer, Sodium Benzoate, PVM/MA Copolymer, Poloxamer 407, Xanthan Gum, Sodium Hydroxide, Benzyl Alcohol.

  • Questions or Comments ? 1-855-255-6722 www.OraProPaste.com

  • Principal Display Panel 

    OraPro Paste    NDC 83610-1060-1

    Advanced Biofilm Removal

    Fluoride AnitCavity Toothpaste

    NET WT 5.2 OZ (147g)

    OraPro 550202S Carton

    OraPro 250202S Tube

  • INGREDIENTS AND APPEARANCE
    ORAPRO FLUORIDE ANTICAVITY 
    fluoride toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83610-1060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CELLULOSE GUM (UNII: K679OBS311)  
    CALCIUM CARBOXYMETHYL CELLULOSE (UNII: UTY7PDF93L)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYL VINYL ETHER AND MALEIC ACID COPOLYMER (1750000 WAMW) (UNII: 9F20VSM0VU)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83610-1060-11 in 1 CARTON06/30/2025
    1147 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02106/30/2025
    Labeler - Protegera, Inc. (119027090)
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