Dr. Sheffield Fluoride Anticavity (Fluoride Anticavity Toothpaste) Paste, Dentifrice [Faria Llc Dba Sheffield Pharmaceutcials] -

DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS]
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NDC	11527-016-63
Set ID	6653e34d-9563-4292-bf37-b4e0f0e3b5cd
Category	HUMAN OTC DRUG LABEL
Packager	Sheffield Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number	PART355

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Drug Facts:
Active Ingredient:

Sodium fluoride - 0.243%
PURPOSE

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 REACH OF CHILDREN

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 -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

INGREDIENTS AND APPEARANCE

DR. SHEFFIELD FLUORIDE ANTICAVITY
fluoride anticavity toothpaste paste, dentifrice

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11527-016-63	1 in 1 CARTON	01/02/2006
1		85 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

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

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