PLUS WHITE COFFEE DRINKERS WHITENING- sodium monofluorophosphate paste

Plus White Coffee Drinkers Whitening by

Drug Labeling and Warnings

Plus White Coffee Drinkers Whitening by is a Otc medication manufactured, distributed, or labeled by CCA Industries, Inc., Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Sodium Monofluorophosphate (0.15% w/v fluoride ion)

Purpose

Anticavity whitening toothpaste

Use

Aids in the removal of stains and prevention of dental decay.

Warnings

 under 6 years of age. 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

under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• This toothpaste is formulated for adults 18 and over who drink coffee - It should not be utilized by children under 18 years old without consulting a dentist or physician
• Brush teeth thoroughly, preferably after each meal, or at least twice a day, or when new stains are apparent.

Inactive ingredients

Sorbitol, Water (Aqua), Hydrated Silica, Dicalcium Phosphate, Glycerin, Sodium Lauryl Sulfate, PVM/MA Copolymer, Flavor, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin.

Questions or comments?

Call Toll Free1-800-595-6230 - www.pluswhite.com

Package Labeling:

INGREDIENTS AND APPEARANCE

PLUS WHITE COFFEE DRINKERS WHITENING 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-7224
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-7224-3	1 in 1 PACKAGE	06/12/2010
1		100 g in 1 PACKAGE; 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	06/12/2010

Labeler - CCA Industries, Inc. (106771041)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead, Inc.		078584069	manufacture(61543-7224)