DR. SHEFFIELD FLUORIDE ANTICAVITY- fluoride anticavity toothpaste paste, dentifrice 
Sheffield Pharmaceuticals 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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Drug Facts:

Active Ingredient:

Sodium fluoride - 0.243%

Anticavity toothpaste

Uses:

  • 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 the reach of children under 6 years of age.

Directions:

  • Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Chlidren under 2 years of age: Conmsult a dentist or doctor.

Inactive ingredients:

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

Principal Display Panel - 3 oz - Carton

Dr. Sheffields NDC 11527-016-63

SHEAF-FIELD TM ADA Accepted

Cavity Protection

Sheffield FLUORIDE ANTICAVITY TOOTHPASTE

NET WT. 3 oz. ( 85g) MADE IN THE USA

Principal Display Panel - 3 oz - Carton

Principal Display Panel 3 oz -Tube

Dr. Sheffields NDC 11527-016-63

SHEAF-FIELD TM ADA Accepted

Cavity Protection

Sheffield FLUORIDE ANTICAVITY TOOTHPASTE

NET WT. 3 oz. ( 85g) MADE IN THE USA

Principal Display Panel 3 oz -Tube

DR. SHEFFIELD FLUORIDE ANTICAVITY 
fluoride anticavity toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-016
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:11527-016-631 in 1 CARTON01/02/200609/30/2018
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/02/200609/30/2018
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(11527-016)

Revised: 9/2022
 
Sheffield Pharmaceuticals LLC