TANNERS TASTY CHA CHA CHOCOLATE- sodium fluoride paste, dentifrice

Tanners Tasty Cha Cha Chocolate by

Drug Labeling and Warnings

Tanners Tasty Cha Cha Chocolate by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

Inactive Ingredients: Sorbitol, Purified Water, Hydrated Silica, Xylitol, Glycerin, Cocamidopropyl Betaine, Flavor, Cellulose Gum, Titanium Dioxide, Disodium Phosphate, Sucralose

Principal Panel 4.2 OZ Tube

Tanner Tasty Paste                     NDC: 11527-044-58

0.243% Sodium Fluoride Toothpaste

Cha -Cha -Chocolate 

NET WT. 4.2 oz (119g)

INGREDIENTS AND APPEARANCE

TANNERS TASTY CHA CHA CHOCOLATE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-044
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)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-044-58	119 g in 1 TUBE; Type 0: Not a Combination Product	08/26/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	08/26/2010

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-044)