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DR DENTAL CARE 80ML

Dosage form: liquid
Ingredients: SODIUM FLUORIDE 0.016mg in 80mL
Labeler: Jangin Pharm Co., Ltd.
NDC Code: 69255-030

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

DR DENTAL CARE 80ML 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69255-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.016 mg  in 80 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 
Packaging
#Item CodePackage Description
1NDC:69255-030-0180 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/FEIOperations
Jangin Pharm Co., Ltd.688733680manufacture(69255-030)

Revised: 09/2014
 
Jangin Pharm Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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