Label: HOUSE LIVING- sodium fluoride,potassium nitrate 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 13, 2017

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  • Active Ingredient

    SODIUM FLUORIDE 0.15%

    Potassium Nitrate 5%

  • Purpose

    Antihypersensitivity

    Anticavity

  • Use

    bulids increasing protection against painful sensitivity of the teeth due to cold,heat,acids,sweets or contact

    aids in the privention of dental cavities

  • Warning

    Stop use and ask a dentist if

    the problem pensists os worsens,sensitive teeth may indicate a serious problem that may prompt care by a dentist

    pain/sensitivity still persists after 4 weeks of use.

  • Directions

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

    instruct children 6 years of age in good brushing and rinsing habits(to minimize swallowing)

    suprevise children as necessary untill capable of using without supervision.

    children under 2 years of age :consult a dentist or doctor

  • Inactive Ingredients

    Water,Silica (Thickening 10 & Friction 4)
    ,Sodium Lauryl Alcohol,Sorbitol,Polyethylene Glycol 300,Sodium Carboxymethylcellulose,Flavor,Sodium Saccharin,Titanium Dioxide,Sodium Pyrophosphate,PEG/PPG 116/66 copolymer
    Sodium Hydroxide,Acid Yellow 23,Acid Blue 1

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.



    If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HOUSE LIVING 
    sodium fluoride,potassium nitrate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71704-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE DECAHYDRATE (UNII: IY3DKB96QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71704-002-0124 in 1 CARTON07/10/2016
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/10/2016
    Labeler - Guangzhou Beauty Cosmetic Co., Ltd (528735414)
    Registrant - Guangzhou Beauty Cosmetic Co., Ltd (528735414)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Beauty Cosmetic Co., Ltd528735414manufacture(71704-002)
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