CARDINAL HEALTH FLUORIDE ANTICAVITY- fluoride anticavity toothpaste paste, dentifrice 
Cardinal Health

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.

----------

Drug Facts:

NDC (63517-016-96)

Active Ingredient:

Sodium fluoride - 0.243% w/w

Purpose

Anticavity toothpaste

Uses:

Warnings:

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

Directions:

Inactive ingredients:

Cellulose Gum, Flavor, Disodium Phosphate,  and FD&C Blue No. 1, Glycerin, Hydrated Silica, PEG 6, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water

Principal Display Panel - .85oz  144 count Box

Principal Display Panel - .85oz  144 count Box

anticavity toothpaste with fluoride

ADA accepted

Principal Display Panel - .85oz  144 count Box

Principal Display Panel .85 oz -Tube

anticavity toothpaste with fluoride

Cardinal Health                      net wt. 0.85oz ( 24g)

Principal Display Panel .85 oz -Tube

CARDINAL HEALTH FLUORIDE ANTICAVITY 
fluoride anticavity toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-016
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PEG-6 STEARATE (UNII: 8LQC57C6B0)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63517-016-96144 in 1 CASE09/09/2013
124 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/09/2013
Labeler - Cardinal Health (961027315)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(63517-016)

Revised: 12/2019
Document Id: 1ab1ab30-2c3b-478f-9c9a-b28b058828ad
Set id: cd5570d9-83b6-441b-a0c1-43d95b6b61f4
Version: 2
Effective Time: 20191230
 
Cardinal Health