DR DENTAL CARE 80ML- sodium fluoride liquid

DR DENTAL CARE 80ML by

Drug Labeling and Warnings

DR DENTAL CARE 80ML by is a Otc medication manufactured, distributed, or labeled by Jangin Pharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DR DENTAL CARE 80ML 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69255-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.016 mg  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69255-030-01	80 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/01/2014

Labeler - Jangin Pharm Co., Ltd. (688733680)

Registrant - Jangin Pharm Co., Ltd. (688733680)

Establishment
Name	Address	ID/FEI	Business Operations
Jangin Pharm Co., Ltd.		688733680	manufacture(69255-030)