Label: DR DENTAL CARE 250ML- sodium fluoride liquid

  • 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 29, 2014

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient:
    Sodium fluoride 0.02% (0.009% w/v fluoride ion)

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Alcohol (3%), Xylitol, Glycerin, Allantoin, Citric Acid, Sodium Citrate, Catechins, Sodium Benzoate, Menthol, Red Ginseng, Sophora Angustifolia Root, Swertia, Licorice, Caramel

  • PURPOSE

    Purpose: Anticavity

  • WARNINGS

    Warning:
    1. Keep out of reach of children under 6 years old.
    2. Avoid direct sunlight, store in room temperature.
    3. Close lid after use.
    4. Consult doctor before use if you are allergic to any of the ingredients.
    5. If significant amount is accidentally swallowed, drink large amount of milk and get medical help.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    If significant amount is accidentally swallowed, drink large amount of milk and get medical help.

  • Use

    Use:
    Mouthwash with outstanding oral disease prevention effect

  • Directions

    Directions:
    Rinse mouth with 10-15ml for 30 seconds.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR DENTAL CARE 250ML 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69255-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 mg  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69255-020-01250 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/01/2014
    Labeler - Jangin Pharm Co., Ltd. (688733680)
    Registrant - Jangin Pharm Co., Ltd. (688733680)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jangin Pharm Co., Ltd.688733680manufacture(69255-020)
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!