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2080 K Herbal Mint

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.12g in 120g
Labeler: Aekyung Industrial Co., Ltd.
NDC Code: 67225-0006

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: 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

2080 K HERBAL MINT 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-0006
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.12 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL72 g  in 120 g
SODIUM LAURYL SULFATE3.12 g  in 120 g
CARBOXYMETHYLCELLULOSE SODIUM0.6 g  in 120 g
SACCHARIN SODIUM0.156 g  in 120 g
SILICON DIOXIDE0.12 g  in 120 g
PHOSPHORIC ACID22.8 g  in 120 g
WATER12.07 g  in 120 g
PANTHENOL0.6 g  in 120 g
POLYETHYLENE GLYCOL 15000.006 g  in 120 g
FD&C BLUE NO. 10.00156 g  in 120 g
SODIUM CHLORIDE 
GINKGO 
ERYTHRITOL 
D&C YELLOW NO. 10 
Packaging
#Item CodePackage Description
1NDC:67225-0006-11 TUBE in 1 PACKAGE
1120 g in 1 TUBE
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/FEIOperations
Aekyung Ind. Co., Ltd._Chungyang Factory690511126manufacture(67225-0006)

Revised: 01/2017
 
Aekyung Industrial 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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