2080 K ORIGINAL- sodium fluoride paste

2080 K Original by

Drug Labeling and Warnings

2080 K Original by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd., Aekyung Ind. Co., Ltd._Chungyang Factory, AK AMERICA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Sodium Fluoride 0.22% (0.1% w/v fluoride)

PURPOSE

Purpose: anticavity

WARNINGS

Do not use this product for purposes other than those described on the label.  In case of eye contact, rinse off immediately with water.  If irritation persists, seek medical help.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age

STOP USE

Stop using this product and consult your dentist if irritation to gums, teeth, or oral mucosa occurs

INDICATIONS & USAGE

Do not swallow.  Rinse mouth with water after brushing.

Children under 6 years:

    - To minimize swallowing, use a pea-sized amount.  Supervise brushing until good habits are established.

    - If swallowed more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

This toothpaste contains 1,000 ppm fluoride

INACTIVE INGREDIENT

Inactive Ingredients: Liquid Sorbitor, Water, Silicon Dioxide, Polyethylene Glycol 1500, Sodium Lauryl Sulfate Flavor, Sodium Chloride, Sodium Carboxymethylcellulose, Saccharin Sodium Hydrate, Phosphoric Acid, Panthenol, Ginkgo Biloba Leaf Extract, Erythritol, Yellow#203, Blue#1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

2080 K ORIGINAL 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-0007
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.12 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)	72 g  in 120 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	3.12 g  in 120 g
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	0.6 g  in 120 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	0.156 g  in 120 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.12 g  in 120 g
PHOSPHORIC ACID (UNII: E4GA8884NN)	22.8 g  in 120 g
WATER (UNII: 059QF0KO0R)	12.07 g  in 120 g
PANTHENOL (UNII: WV9CM0O67Z)	0.6 g  in 120 g
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)	0.006 g  in 120 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.00156 g  in 120 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GINKGO (UNII: 19FUJ2C58T)
ERYTHRITOL (UNII: RA96B954X6)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-0007-1	1 in 1 PACKAGE	07/07/2016
1		120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/07/2016

Labeler - Aekyung Industrial Co., Ltd. (687995647)

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Ind. Co., Ltd._Chungyang Factory		690511126	manufacture(67225-0007)

Establishment
Name	Address	ID/FEI	Business Operations
AK AMERICA		690064554	pack(67225-0007)