Label: ORTHOCARE- sodium fluoride paste, dentifrice

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

Drug Label Information

Updated November 20, 2023

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  • Inactive Ingredient

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

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warnings

  • 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.

  • Other Information:

    For your protection, this tube has a foil seal under the cap.

  • Directions

    • Adults and children 2 years of age and older: Use a pea sized amount and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children's brushing until good habits are established.
    • Children under 2 years: Consult a dentist or doctor.
  • Inactive Ingredients

    Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Lysine, Arginine, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, Cellulose Gum, Alanine, Sodium Benzoate, Disodium Phospate, Sodium Saccharin, FD&C Blue #1

  • Questions?

    1-833-261-0246

  • Principal Display

    OrthoSciences™

    ORTHOCARE

    Specially formulated for those with braces

    NET WT. 4.4 OZ. (125 grams) Anticavity Fluoride Toothpaste

    orthocare_toothpaste_image.jpg

  • INGREDIENTS AND APPEARANCE
    ORTHOCARE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73051-0754
    Route of AdministrationDENTAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALANINE (UNII: OF5P57N2ZX)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MINT (UNII: FV98Z8GITP)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ARGININE (UNII: 94ZLA3W45F)  
    LYSINE (UNII: K3Z4F929H6)  
    SODIUM LAURYL PHOSPHATE (UNII: 9ECT856LYU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73051-0754-1125 g in 1 TUBE; Type 0: Not a Combination Product04/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/17/2019
    Labeler - Orthosciences, Inc. (044448056)
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