DENTAL CLINIC 2080 K STRONG WINTER GREEN- sodium fluoride paste, dentifrice

Dental Clinic 2080 K Strong Winter Green by

Drug Labeling and Warnings

Dental Clinic 2080 K Strong Winter Green by is a Otc medication manufactured, distributed, or labeled by Aekyung Ind. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dental Clinic 2080 K Toothpaste Strong Winter Green

Active Ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

do not swallow.

supervise children as necessary until capable of using without supervision.

Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.

Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Liquid Sorbitol, Dental-Type Silica, Sodium Chloride, Sodium Lauryl sulphate, Sodium carboxymethylcellulose, Panthenol, Polyethylene Glycol 1500, Saccharin Sodium Hydrate, Phosphoric acid, Water

SPL UNCLASSIFIED SECTION

Dental Clinic 2080 Gingivalis Project K

Gingivitis-causing Bacteria

99% Inhibits

in-vitro test Results

Tested by Dental School Clinic

Dental Clinic 2080 K Toothpaste Citrus Cool Mint

OTC Drug

Customer Center:060-024-1357 (Nationwide Toll-Free)

We accept returns in compliance with the Consumer Protection Act of Fair Trade Commission.

AEKYUNG

MADE IN KOREA

www.aekyung.co.kr

Net Weight: 100g

Dental Clinic 2080 K Toothpaste Strong Winter Green, 100g (

67225-0002-1)

INGREDIENTS AND APPEARANCE

DENTAL CLINIC 2080 K STRONG WINTER GREEN 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-0002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYGLUCOSE SORBITOL CARBOXYMETHYL ETHER (UNII: Y8P5S7CF2S)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PANTHENOL (UNII: WV9CM0O67Z)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	WINTERGREEN (Strong Winter Green)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-0002-1	1 in 1 PACKAGE
1		100 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/16/2014

Labeler - Aekyung Ind. Co., Ltd. (690511126)

Registrant - Aekyung Ind. Co., Ltd. (690511126)

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Ind. Co., Ltd.		690511126	manufacture(67225-0002)