DOCTORTIBLETKEREALE- sodium fluoride paste, dentifrice 
TRAUM TRADERS

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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ACTIVE INGREDIENT

Active ingredients: Sodium Fluoride 0.22%

INACTIVE INGREDIENT

Inactive ingredients: D-Sorbitol, Sodium Lauryl Sulfate, Silicon Dioxide, Xylitol, microcrystalline cellulose, Mint Flavor, Magnesium Sterate, L-Menthol, Hydroxypropylellulose, Tetrasodium Pyrophosphate, sodium hydrogen carbonate, aspartame, Arabic Gum, Pyridoxine HCI, Ascorbic Acid

PURPOSE

Purpose: Anticaries

WARNINGS

Warnings: Keep out of the reach of children under 6 years of age. Do not use children because they may swallow. If large quantities have been swallowed, consult a physician immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age.

Uses

Uses: Help better oral hygiene and freshness breath.

Directions

Directions: Take one of Kereale mouth rinse tablet chewing until it melting completely in your mouth and mix with some water then spit it out.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DOCTORTIBLETKEREALE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72047-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.001 g  in 0.7 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72047-010-0260 in 1 CARTON01/02/2018
1NDC:72047-010-010.7 g in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/02/2018
Labeler - TRAUM TRADERS (694894613)
Registrant - TRAUM TRADERS (694894613)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd689787898manufacture(72047-010)

Revised: 1/2018
Document Id: 9445c4dc-3e6d-4250-aac7-06a826046e71
Set id: 9927bc9e-84e5-4b08-b729-ec2769b4cbd3
Version: 1
Effective Time: 20180129
 
TRAUM TRADERS