LINHART- sodium fluoride toothpaste paste, dentifrice 
Linhart Inc

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 Fact 

Active ingredient

Sodium Fluoride 0.25%

Purpose 

Anticavity

Uses

Aids in the prevention of tooth 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 the 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 Barbadenias Leaf Juice, Allantoin, Sodium Saccharin, Theobromine, Bisabolol

Principal Primary Panel - Carton 3.5oz

Principal Primary Panel - Carton 3.5oz

LINHART with Linamel

Fluoride Toothpaste

NET WT 3.5oz(99g)

Principal Primary Panel - Carton 3.5oz

Principal Primary Panel - Tube 3.5oz

Principal Primary Panel - Tube 3.5oz

LINHART with Linamel

Fluoride Toothpaste

NET WT 3.5oz (99g)

Principal Primary Panel - Tube 3.5oz

LINHART 
sodium fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70926-100
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)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALLANTOIN (UNII: 344S277G0Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
THEOBROMINE (UNII: OBD445WZ5P)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70926-100-641 in 1 CARTON08/17/2017
199 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70926-100-341 in 1 CARTON08/17/2017
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/17/2017
Labeler - Linhart Inc (080343587)

Revised: 3/2021
Document Id: 58a832be-5feb-47c7-badd-0a59c10399cc
Set id: 937d0a02-2ed7-4207-9bbe-2b8017815d68
Version: 2
Effective Time: 20210322
 
Linhart Inc