NUGA TOURCIA

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.18g in 180g
Labeler: NUGA MEDICAL CO., LTD.
NDC Code: 43275-100

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.

Drug Facts

Active ingredient: SODIUM MONOFLUOROPHOSPHATE 0.1%

Inactive ingredients:
D-Sorbitol Solution, Silicon Dioxide, Purified Water, Concentrated Glycerin, Sodium Lauryl Sulfate, Polyethylen Glycol-1500, Carboxymethylcelluolose Sodium, L-Menthol, Peppermint Oil, Methyl paraben, Glucosyl Stevia, Xylitol, Chitosan, Grapefruit Seed Extract, Aloe Extract, Mica, Argentum

Purpose:
It removes dental plaque.
It keeps your oral cavity clean.
It keeps your oral cavity pleasant.

Warnings:
1. The content of fluorine in this toothpaste is 132ppm.(Total content shall be 1,000ppm or less.)
2. Apply a small amount of toothpaste in a size of a pea every round under a guardian's instructions to prevent the child from sucking and swallowing, if a child at the age of 6 or younger uses this product.
3. Immediately consult with a doctor or a dentist if a child at the age of 6 or younger swallowed a lot of toothpaste.
4. Keep the product in a place where a child at the age of 6 or younger can not reach.

Keep out of reach of children:
If accidentally swallowed, get medical help or contact a poison control center right away.

Indication and usage:
Adults at least a half-inch strip of the product onto a soft bristle tooth brush.
Brush teeth thoroughly for at least 3 minutes twice a day. (Morning and evening)

Dosage and administration:
Adults at least a half-inch strip of the product onto a soft bristle tooth brush.
Brush teeth thoroughly for at least 3 minutes twice a day. (Morning and evening)

NUGA TOURCIA 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43275-100
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.18 g  in 180 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
WATER 
GLYCERIN 
SODIUM LAURYL SULFATE 
LEVOMENTHOL 
PEPPERMINT OIL 
METHYLPARABEN 
XYLITOL 
GRAPEFRUIT SEED OIL 
ALOE 
MICA 
Packaging
#Item CodePackage Description
1NDC:43275-100-01180 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2011
Labeler - NUGA MEDICAL CO., LTD. (690034673)
Registrant - NUGA MEDICAL CO., LTD. (690034673)
Establishment
NameAddressID/FEIOperations
NUGA MEDICAL CO., LTD.690034673manufacture

Revised: 04/2012
 
NUGA MEDICAL 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.

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