Label: ORAL7- sodium monofluorophosphate paste

  • 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 January 8, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Monofluorophosphate 0.76% w/w (1000ppmF)

  • Purpose

    Anti-cavity

  • 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. If symptoms of dry mouth persist, consult a health care professional.

    DO NOT use if you are allergic to any of the ingredients.

  • Directions

    Adults and Children 2 years of age and older

    • Use 2-3 times a day, 7 days a week.
    • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist
    • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

    Children under 2 years of age: Consult a dentist or doctor.

  • Other Information

    Store below 77°F (25°C).

  • Ingredients

    Sorbitol, Dicalcium Phosphate, Glycerin, Hydrated Silica, Dextrose Monohydrate, Silica, Isoceteth-20, Xylitol, Water, Cellulose Gum, Sodium Benzoate, Lactoperoxidase , Mentha Piperita (Peppermint Oil-includes limonene), Potassium Thiocyanate, Menthol, Lactoferrin , Lysozyme, Glucose Oxidase, Calcium Lactate

  • Questions or Comments?

    Call Tel. : 908-420-3759 weekdays or, email us: info@fountainhealthcarellc.com

  • PRINCIPAL DISPLAY PANEL - 105 g Tube Carton

    NDC 69297-000-19

    Oral 7®Xylitol
    balancing your mouth's natural flora

    Beneficial for the
    whole family!

    ✓
    No SLS (harsh drying detergent)
    ✓
    With Fluoride & Calcium
    ✓
    Extra Beneficial for Dry Mouth

    MOISTURIZING
    TOOTHPASTE

    With natural enzymes to
    help reinforce your
    mouth's own defense system

    75mL (105g) e

    PRINCIPAL DISPLAY PANEL - 105 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ORAL7 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69297-000
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MYELOPEROXIDASE (UNII: JQZ6YM58U5)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    POTASSIUM THIOCYANATE (UNII: TM7213864A)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    LACTOFERRIN, BOVINE (UNII: KG21X1090A)  
    LYSOZYME (UNII: 968JKA7T33)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    CALCIUM LACTATE (UNII: 2URQ2N32W3)  
    Product Characteristics
    ColorWHITE (TO OFF WHITE) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69297-000-191 in 1 CARTON
    1105 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/01/2015
    Labeler - JCEC Company, Inc. (961973299)
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