Vita Fresh

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1.125g in 150g
Labeler: Cellinbio Co Ltd
NDC Code: 76173-1003

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)

VITA FRESH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76173-1003
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE1.125 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
ALUMINUM CHLOROHYDRATE 
SORBITOL 
POLYETHYLENE GLYCOL 1500 
HYDRATED SILICA 
CARBOXYMETHYLCELLULOSE SODIUM 
XYLITOL 
SACCHARIN SODIUM 
SODIUM LAURYL SULFATE 
GREEN TEA LEAF 
LEVOMENTHOL 
SPEARMINT OIL 
BETA CAROTENE 
FD&C YELLOW NO. 5 
GOLD 
WATER 
Product Characteristics
Coloryellow (green and black) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:76173-1003-21 TUBE (TUBE) 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/FEIOperations
Cellinbio Co Ltd557803737relabel
Establishment
NameAddressID/FEIOperations
KOLMAR KOREA CO LTD687846360manufacture

Revised: 07/2011
 
Cellinbio Co Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)