VITA FRESH - sodium monofluorophosphate paste, dentifrice 
Cellinbio Co Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Vita Fresh Toothpaste

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)

image of carton label

VITA FRESH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76173-1003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE1.125 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (green and black) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76173-1003-21 in 1 BOX
1NDC:76173-1003-1150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/27/2011
Labeler - Cellinbio Co Ltd (557803737)
Registrant - Cellinbio Co Ltd (557803737)
Establishment
NameAddressID/FEIBusiness Operations
Cellinbio Co Ltd557803737relabel
Establishment
NameAddressID/FEIBusiness Operations
KOLMAR KOREA CO LTD687846360manufacture

Revised: 7/2011
Document Id: 3eaf2422-e6e7-45ed-afbd-8dd677ce8e7e
Set id: 6a708e50-ab4c-4eab-954d-f24780a324a3
Version: 1
Effective Time: 20110727
 
Cellinbio Co Ltd