Label: HOUSE LIVING- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 8, 2017

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

View All Sections
  • Active ingredients

    SODIUM MONOFLUOROPHOSPHATE 0.76%

    Purpose

    anticavity

  • Uses

    Regular brushing with fluoride toothpaster helps protect teeth and roots against cavities.

  • Warnings

    Keep out of the reach of children under 6 years of age.if more than used for brushing is accidentally swalowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children.

  • Directions

    Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a doctor.

    Children under 6 years of age ,in good brushing and rinsing habits (to minimize swallowing),

    supervise children as necessary until capable of useing without supervision.

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

  • INACTIVE INGREDIENT

    Water,Silica ,Calcium Carbonate,Sodium Lauryl Alcohol,Sorbitol,Polyethylene Glycol 400, Sodium Carboxymethylcellulose,Sodium Saccharin,Sodium Hydroxide,Methyl Paraben,Propylparaben,Flavor

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HOUSE LIVING 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71704-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71704-001-0124 in 1 CARTON09/13/2017
    1128 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/13/2017
    Labeler - Guangzhou Beauty Cosmetic Co., Ltd (528735414)
    Registrant - Guangzhou Beauty Cosmetic Co., Ltd (528735414)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Beauty Cosmetic Co., Ltd528735414manufacture(71704-001)
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!