VITA FRESH- sodium monofluorophosphate paste, dentifrice

Vita Fresh by

Drug Labeling and Warnings

Vita Fresh by is a Otc medication manufactured, distributed, or labeled by Cellinbio Co Ltd, KOLMAR KOREA CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient
Sodium monofluorophosphate 0.75%

Purpose

Anticaries

Keep out of Reach of Children

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.

Indication & Usage

Directions
Do not swallow
Supervise children as necessary until capable of using without supervision
Adults, Children 6 years of age, older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
Children under 6 years: Use only a pea sized amount and supervise child's brushing and rinsing(to minimize swallowing).
Children under 2 years: ask a dentist or doctor.

Warnings

Warnings
Stop use and ask a dentist if problems persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist.

Dosage & Administration

Enter section text here

Inactive Ingredient

Silica, Tocopheryl Acetate, Aluminum chlorohydrate, Sorbitol, Polyethylene Glycol 1500, Hydrated silica, Cellulose Gum, Xylitol, Sodium Saccharin, Sodium Lauryl Sulfate, Camellia Sinensis Leaf Extract, Menthol, Mentha Virdis(Spearmint) Leaf Oil, Beta-carotene, CI 19140, CI 77480, Water

Vita Fresh Toothpaste

NRC Vita Fresh Toothpaste

Net WT. 5.29 OZ(150g)

INGREDIENTS AND APPEARANCE

VITA FRESH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76173-1003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	1.125 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LEVOMENTHOL (UNII: BZ1R15MTK7)
SPEARMINT OIL (UNII: C3M81465G5)
BETA CAROTENE (UNII: 01YAE03M7J)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GOLD (UNII: 79Y1949PYO)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (green and black)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76173-1003-2	1 in 1 BOX
1	NDC: 76173-1003-1	150 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/27/2011

Labeler - Cellinbio Co Ltd (557803737)

Registrant - Cellinbio Co Ltd (557803737)

Establishment
Name	Address	ID/FEI	Business Operations
Cellinbio Co Ltd		557803737	relabel

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR KOREA CO LTD		687846360	manufacture