TANNERS TASTY VANILLA BLING- sodium fluoride paste, dentifrice

Tanners Tasty Vanilla Bling by

Drug Labeling and Warnings

Tanners Tasty Vanilla Bling 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:

Sorbitol, Purified Water, Hydrated Silica, Xylitol, Glycerin, Cocamidopropyl Betaine, Flavor, Titanium Dioxide, Carboxymethylcellulose, Sodium Phosphate, Sucralose, Citric Acid

Principal Panel 4.2 OZ Tube

Tanner Tasty Paste                     NDC: 11527-180-58

0.243% Sodium Fluoride Toothpaste

Vanilla Bling 

NET WT. 4.2 oz (119g)

INGREDIENTS AND APPEARANCE

TANNERS TASTY VANILLA BLING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-180
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)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-180-58	119 g in 1 TUBE; Type 0: Not a Combination Product	07/10/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/10/2012

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-180)