2080 DENTISTRY NIGHT FRESH (dental type silica- silicon dioxide, zinc citrate, trihydrate, cetylpyridinium chloride, dipotassium glycyrrhizinate paste, dentifrice

2080 Dentistry Night Fresh by

Drug Labeling and Warnings

2080 Dentistry Night Fresh by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd., Aekyung Ind. Co., Ltd._Chungyang Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active Ingredients: ​Purpose
• Dental-Type Silica 15%: Anticavity
• Zinc Citrate, trihydrate 0.5%: Anti Oral Malodor
• Cetylpyridinium Chloride 0.05%: Antigingivitis
• Dipotassium Glycyrrhizinate 0.01%: Antigingivitis

WARNINGS

Be careful not to swallow.  Rinse your mouth thoroughly after use.  Consult a doctor or dentist if gum problems occur after using this toothpaste.

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

DOSAGE & ADMINISTRATION

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.

INDICATIONS & USAGE

- Removes bad breath

- Maintains oral health

INSTRUCTIONS FOR USE

Directions: Apply suitable amount of toothpaste to toothbrush

DO NOT USE

Do not use for purpose other than brushing teeth.  Rinse with running water in the event that the toothpaste gets in the eye and consult a doctor for adverse reactions

STORAGE AND HANDLING

Store in a sealed container at room temperature {1~30°C}

QUESTIONS

Customer Center: 080-024-1357 (Nationwide Toll-Free)

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

www.aekyung.co.kr

SPL UNCLASSIFIED SECTION

Manufacturer: Aekyung Co., Ltd

1547-9 Chungui-ro, Jeongsan-myeon, Cheongyanggun, Chungcheongnam-do, Korea

INACTIVE INGREDIENT

Inactive Ingredients: Liquid Sorbitol (Non-crystalizing), Glycerin, Polyethylene Glycol 1500, Sodium Alginate, Trisodium Citrate, Saccharin Sodium Hydrate, Cocamidopropyl Betain, Sodium Lauryl Sulfate, Sodium N-Cocoyl-N-Methyl Taurate Solution, Titanium Dioxide, Thymus Vulgaris (Thyme) Leaf Extract, Cymbopogon Citratus Extract, Pelargonium Graveolens Extract, Cinnamonium Zeylanicum Bark Extract, Foenlculum Vulgare (Fennel) Seed Extract, Rosemarinus Officinalis (Rosemary) Leaf Extract, Eugenia Caryphyllus (Clove) Flower Extract, Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

2080 DENTISTRY NIGHT FRESH 
dental type silica (silicon dioxide), zinc citrate, trihydrate, cetylpyridinium chloride, dipotassium glycyrrhizinate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-0009
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
ZINC CITRATE TRIHYDRATE (UNII: GNM26GAX7R)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
CYMBOPOGON CITRATUS WHOLE (UNII: 6AE8LT94NG)
PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)
CINNAMON BARK OIL (UNII: XE54U569EC)
FENNEL SEED (UNII: G3QC02NIE6)
ROSEMARY (UNII: IJ67X351P9)
CLOVE (UNII: K48IKT5321)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-0009-1	1 in 1 CARTON	02/03/2017
1		100 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	part332	02/03/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Ind. Co., Ltd._Chungyang Factory		690511126	manufacture(67225-0009)