CARDINAL HEALTH FLUORIDE ANTICAVITY- fluoride anticavity toothpaste paste, dentifrice

Cardinal Health Fluoride Anticavity by

Drug Labeling and Warnings

Cardinal Health Fluoride Anticavity by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Faria LLC dba Sheffield Pharmaceutcials. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

NDC (63517-016-96)

Active Ingredient:

Sodium fluoride - 0.243% w/w

Purpose

Anticavity toothpaste

Uses:

• Aids in the prevention of dental decay

Warnings:

• If you accidentally swallow more than used for brushing ,seek 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,  after meals or at least twice a day, or as directed by a dentist or physician.
• Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing).
• Supervise children as necessary until capable of using without supervision.
• Chlidren under 2 years of age: Consult a dentist or physician.

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

anticavity toothpaste with fluoride

ADA accepted

Principal Display Panel .85 oz -Tube

anticavity toothpaste with fluoride

Cardinal Health                      net wt. 0.85oz ( 24g)

INGREDIENTS AND APPEARANCE

CARDINAL HEALTH FLUORIDE ANTICAVITY 
fluoride anticavity toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-016
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-016-96	144 in 1 CASE	09/09/2013
1		24 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/09/2013

Labeler - Cardinal Health (961027315)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(63517-016)