Label: FRAICHE KIDS PASTE, BUBBLE GUM FLAVOR- sodium fluoride paste

  • NDC Code(s): 83592-803-46
  • Packager: True Marker Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 27, 2024

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  • Active Ingredient 

    0.24% w/w Sodium Fluoride

  • Purpose

    Anti-cavity

  • Uses

     Aids in the prevention of dental cavities.

  • Warnings

    Keep out of reach of children under 6 years of age. If more than the recommended amount of the paste used for brushing is
    accidentally swallowed, get medical help or contact the Poison Control Center right away. In case of an allergic reaction, stop use, rinse mouth with water and seek medical advice.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    For adults and children 2 years of age or older, apply a small peasized amount of FRAICHE Kids dental gel to your toothbrush. For best results,

    brush for 2 minutes, expectorate and avoid eating or drinking for 30 minutes after brushing. Use twice daily. Replace cap after use.

    For children under 2 years of age, consult a dentist or physician.

  • Other information

    • Store at controlled room temperature, 68-77°F (20-25°C).
    • Do not use if safety seal is broke or missing.
  • Inactive Ingredients

    Pure Water, Glycerol, Sorbitol, CMC-NA, Propylene Glycol, Silicon Dioxide, Titanium Dioxide, Xylitol, Phosphoric Acid, Flavoring, Sodium
    Saccharin, Ethyl P-hydroxybenzoate, Propyl P-hydroxybenzoate, Butyl P-hydroxybenzoate, Sodium-N-lauroyl Sarcosinate.

  • Questions or Comments?

    Call 1-888-811-2634
    www.truemarkerpharma.com

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    FRAICHE KIDS PASTE, BUBBLE GUM FLAVOR 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83592-803
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ETHYLPARABEN POTASSIUM (UNII: 528JBB2994)  
    BUTYL SALICYLATE (UNII: QPR9LM8VZO)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83592-803-461 in 1 BOX06/20/2024
    146 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02106/20/2024
    Labeler - True Marker Pharmaceuticals, Inc. (119046582)
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