2080 K ORIGINAL- sodium fluoride paste 
Aekyung Industrial 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.

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

Purpose: anticavity

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 the reach of children under 6 years of age

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

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.

This toothpaste contains 1,000 ppm fluoride

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

Label

2080 K ORIGINAL 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-0007
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67225-0007-11 in 1 PACKAGE07/07/2016
1120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/07/2016
Labeler - Aekyung Industrial Co., Ltd. (687995647)
Establishment
NameAddressID/FEIBusiness Operations
Aekyung Ind. Co., Ltd._Chungyang Factory690511126manufacture(67225-0007)
Establishment
NameAddressID/FEIBusiness Operations
AK AMERICA690064554pack(67225-0007)

Revised: 4/2017
Document Id: 231fd48c-a6ce-46b3-b90a-e5a39f92e260
Set id: cfab0efc-1626-4c57-b8b0-a16b6b10773a
Version: 4
Effective Time: 20170425
 
Aekyung Industrial Co., Ltd.