DR. SHEFFIELD FLUORIDE ANTICAVITY- sodium fluoride paste, dentifrice
Faria LLC dba Sheffield Pharmaceutcials

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

Pricipal Display Panal - 3 oz - Carton

5441591 Sheffield ADA Fluoride 3oz.jpg

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 Panal 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

DR. SHEFFIELD FLUORIDE ANTICAVITY
fluoride anticavity toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11527-016
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	2.43 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL
WATER
HYDRATED SILICA
GLYCERIN
SODIUM LAURYL SULFATE
PEG-6 STEARATE
CARBOXYMETHYLCELLULOSE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SACCHARIN SODIUM
TITANIUM DIOXIDE
FD&C BLUE NO. 1

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:11527-016-63	1 in 1 CARTON
1		85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/02/2006

Labeler - Faria LLC dba Sheffield Pharmaceutcials (151177797)

Registrant - Faria LLC dba Sheffield Pharmaceutcials (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Faria LLC dba Sheffield Pharmaceutcials		151177797	manufacture(11527-016)

Revised: 08/2013

Document Id: 23d01fc3-52c6-4926-9c16-54851886a4e5

Set id: 6653e34d-9563-4292-bf37-b4e0f0e3b5cd

Version: 1

Effective Time: 20130806

Faria LLC dba Sheffield Pharmaceutcials