LINHART- sodium fluoride toothpaste paste, dentifrice 
Nutrix International,LLC

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

Sodium Fluoride 0.25%

Purpose

Anticavity

Indications and Usage

Aids in the prevention of dental decay.

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach section

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

Directions

Inactive Ingredients

Sorbitol, Water (Purified), Hydrated Silica, Xylitol, Glycerin, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose Gum,Disodium Phosphate, Aloe Barbadensis Leaf Juice, Allantoin, Sodium Saccharin, Theobromine,Bisobolol.

Questions

(212) 599-2397

Primary Packaging Label

Tube Artwork

Packaging Label - Carton

Carton Artwork

LINHART 
sodium fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73333-096
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
THEOBROMINE (UNII: OBD445WZ5P)  
XYLITOL (UNII: VCQ006KQ1E)  
ALLANTOIN (UNII: 344S277G0Z)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73333-096-031 in 1 CARTON09/25/2019
196 g in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/25/2019
Labeler - Nutrix International,LLC (117341868)
Establishment
NameAddressID/FEIBusiness Operations
Nutrix International, LLC117341868manufacture(73333-096)

Revised: 1/2020
Document Id: 9c49666c-3443-47e6-e053-2a95a90ad7a5
Set id: 9c4997ea-590b-47e0-e053-2a95a90ab4a9
Version: 3
Effective Time: 20200116
 
Nutrix International,LLC