VITA FRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [CELLINBIO CO LTD]

VITA FRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [CELLINBIO CO LTD]
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NDC	76173-1003-1, 76173-1003-2
Set ID	6a708e50-ab4c-4eab-954d-f24780a324a3
Category	HUMAN OTC DRUG LABEL
Packager	Cellinbio Co Ltd
Generic Name
Product Class
Product Number
Application Number	PART355

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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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Cellinbio Co Ltd (557803737)

Registrant - Cellinbio Co Ltd (557803737)

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

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

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