DENTAL CLINIC 2080 FRESH UP- sodium monofluorophosphate paste

Dental Clinic 2080 Fresh Up by

Drug Labeling and Warnings

Dental Clinic 2080 Fresh Up 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]

WARNINGS

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Keep out of reach of children under 6 years of age

Sodium monofluorophosphate 0.75% (0.13% w/v Fluoride ion)

Sodium carboxymethylcellulose, Sodium lauryl sulfate, Sodium saccharin, Sorbitol, Titanium dioxide, Tocopheryl acetate, Water, Hydrated Silica, Menthol, PEG-4, PEG-32, Flavor, Glycerin, Mica, Sage leaf extract, Agar, Alginic acid, Benzethonium chloride, Chamomille flower extract, FD&C Blue No 1

Purpose Anticavity

Adults and children 2 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 doctor.

Instruct children under 6 years of age in good brushing ad rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age

Consult a dentist or doctor

Aids in the prevention of dental cavities

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTAL CLINIC 2080 FRESH UP 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-0005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.156 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
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.12 g  in 120 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)	22.8 g  in 120 g
WATER (UNII: 059QF0KO0R)	12.07 g  in 120 g
MENTHOL (UNII: L7T10EIP3A)	0.6 g  in 120 g
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)	0.006 g  in 120 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.00156 g  in 120 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-0005-1	1 in 1 PACKAGE	04/01/2015
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	04/01/2015

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

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Ind. Co., Ltd._Chungyang Factory		690511126	manufacture(67225-0005)