Label: ORAL7 DRY MOUTH MOISTURIZING- sodium monofluorophosphate paste, dentifrice

  • 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 June 14, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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).

  • Inactive ingredients

    DICALCIUM PHOSPHATE, HYDROGENATED STARCH HYDROLYSATE, GLYCERIN, AQUA, SILICA, DEXTROSE MONOHYDRATE, HYDRATED SILICA, ISOCETETH-20, XYLITOL, SODIUM MONOFLUOROPHOSPHATE, XANTHAN GUM, MENTHA PIPERITA (PEPPERMINT OIL), SODIUM BENZOATE, LACTOPEROXIDASE, POTASSIUM THIOCYANATE, LACTOFERRIN, LYSOZYME, GLUCOSE OXIDASE, LIMONENE, CALCIUM LACTATE

  • Questions

    or Comments? Tel.: +1 833-672-5787 weekdays or Email : info@oral7us.com / oral7us.com

    Always follow the label

  • SPL UNCLASSIFIED SECTION

    ORAL7

    REAL DRY MOUTH RELIEF

    TOOTHPASTE

    Fluoride & Calcium

    2.5 fl oz 75 ml (105g)

    SUGAR FREE

    Naturally Sweetened with Xylitol

    Made in the EU

    Oral7 International Pty. Ltd.

    Suite 2, 15 Delawney Street

    Balcatta, WA 6021 AUSTRALIA

    USA & Canada

    Oral7 U.S. (Op) Inc.info@oral7us.com

    www.oral7us.com

  • PRINCIPAL DISPLAY PANEL

    box

    label

  • INGREDIENTS AND APPEARANCE
    ORAL7 DRY MOUTH MOISTURIZING 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81175-000
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LACTOFERRIN, BOVINE (UNII: KG21X1090A)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MYELOPEROXIDASE (UNII: JQZ6YM58U5)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    POTASSIUM THIOCYANATE (UNII: TM7213864A)  
    LYSOZYME (UNII: 968JKA7T33)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    CALCIUM LACTATE (UNII: 2URQ2N32W3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81175-000-0275 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2019
    Labeler - Oral7 USA Operations Inc (117789267)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!