Label: DENTAL PRO- sodium fluoride mouthwash

  • 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 September 11, 2014

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

View All Sections
  • ACTIVE INGREDIENT

    sodium fluoride


  • INACTIVE INGREDIENT

    purified water, ethyl alcohol, allantoin, glycerin, xylitol, sodium saccharin, green tea, malic acid, lactic acid, sodium benzoate, citric acid peg-40 hydrogenated castor oil, sodium citrate, l-menthol, red ginseng ext, ulmus ext, red ginseng fragrance, mint fragrance, houttuynia ext, propolis ext, caramel color


  • PURPOSE

    for dental care


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    ① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) and
    put into mouth.
    ② Goggle it thoroughly all over the inner mouth about 10 seconds.
    ③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out


  • WARNINGS

    do not swallow


  • DOSAGE & ADMINISTRATION

    for oral administration


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    DENTAL PRO 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41525-6001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41525-6001-1250 mL in 1 BOTTLE
    2NDC:41525-6001-2600 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/11/2014
    Labeler - PBS Co., Ltd. (690329669)
    Registrant - PBS Co., Ltd. (690329669)
    Establishment
    NameAddressID/FEIBusiness Operations
    PBS Co., Ltd.690329669manufacture(41525-6001)
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!