DR DENTAL CARE 750ML- sodium fluoride liquid 
Jangin Pharm Co., Ltd.

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.

----------

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

DR DENTAL CARE 750ML 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69255-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 mg  in 750 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69255-010-01750 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(69255-010)

Revised: 9/2014
Document Id: 1b7c5434-ae74-46e6-91a6-2b096acb414a
Set id: 1a523275-1df9-4ddc-ae3e-c999dec06ffd
Version: 1
Effective Time: 20140929
 
Jangin Pharm Co., Ltd.