PLUS WHITE SMOKERS WHITENING- sodium monofluorophosphate paste, dentifrice

Plus White Smokers Whitening by

Drug Labeling and Warnings

Plus White Smokers 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]

Active Ingredient

Sodium Monofluorophosphate 0.83%  (0.11% w/v fluoride ion)                           

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 the reach of children under 6 years of age.

Directions 

 This toothpaste is formulated for adults 18 and over who smoke tobacco

- 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 INGREDIENT

Inactive ingredients Sorbitol, Hydrated Silica, Water (Purified), Dicalcium Phosphate, Glycerin, PVM/MA Copolymer, Flavor, Sodium lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Blue 1, Yellow 5

QUESTIONS

Questions or comments? Call Toll Free1-800-595-6230
- www.pluswhite.com

Principal Display Panel -Tube 3.5 oz

Plus+White
THE SMOKER'S WHITENING TOOTHPASTE

Net Wt 3.5 oz (100G) - Fluoride Anticavity Toothpaste

Principal Display Panel - Carton 3.5 oz

Plus + White 

The Smokers Whitening Toothpaste 

NET WT 3.5 oz (100G) Fluoride Anticavity Toothpaste 

INGREDIENTS AND APPEARANCE

PLUS WHITE SMOKERS WHITENING 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-1554
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.83 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
TRISODIUM DIPHOSPHATE (UNII: AR7OGW33N1)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-1554-3	1 in 1 CARTON	01/31/2018
1		100 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	01/31/2018

Labeler - CCA Industries, Inc. (106771041)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(61543-1554)