TANNERS TASTY OOH LA LA ORANGE- sodium fluoride paste, dentifrice 
Sheffield Pharmaceuticals LLC

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Tanners Tasty Paste Ooh La La Orange 

Drug Facts:

Active Ingredient:

Sodium fluoride - 0.243%

Anticavity toothpaste

Uses:

Warnings:

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

Directions:

Inactive ingredients:

Inactive Ingredients: Sorbitol, Purified Water, Hydrated Silica, Xylitol, Glycerin, Cocamidopropyl Betaine, Flavor, Cellulose Gum, Titanium Dioxide, Disodium Phosphate, Sucralose

Principal Panel 4.2 OZ Tube

Tanner Tasty Paste                     NDC 11527-045-42

0.243% Sodium Fluoride Toothpaste

Ooh La La Orange 

NET WT. 4.2 oz (119g)

Principal Panel 4.2 OZ Tube

TANNERS TASTY OOH LA LA ORANGE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-045
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-045-42119 g in 1 TUBE; Type 0: Not a Combination Product03/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02103/25/2021
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(11527-045)

Revised: 10/2023
Document Id: 56115203-3364-4196-b1be-6ed903284864
Set id: 6027b961-314e-4f71-8b2f-646ce80214d8
Version: 2
Effective Time: 20231024
 
Sheffield Pharmaceuticals LLC