NUGA TOURCIA- sodium monofluorophosphate paste, dentifrice 
Nuga Medical 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.

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Drug Facts

ACTIVE INGREDIENT

Active ingredient: SODIUM MONOFLUOROPHOSPHATE 0.1%

INACTIVE INGREDIENT

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

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

WARNINGS

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

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

INDICATIONS & USAGE

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 & ADMINISTRATION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of caton

NUGA TOURCIA 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43275-100
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.18 g  in 180 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
XYLITOL (UNII: VCQ006KQ1E)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
ALOE (UNII: V5VD430YW9)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43275-100-01180 g in 1 CARTON; Type 0: Not a Combination Product09/01/201112/31/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/201112/31/2013
Labeler - Nuga Medical Co.,Ltd. (690034673)
Registrant - Nuga Medical Co.,Ltd. (690034673)
Establishment
NameAddressID/FEIBusiness Operations
Nuga Medical Co.,Ltd.690034673manufacture(43275-100)

Revised: 7/2017
 
Nuga Medical Co.,Ltd.