PLUS WHITE- sodium monofluorophosphate paste, dentifrice

Plus White by

Drug Labeling and Warnings

Plus White 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: Glycerin, Hydrated Silica, Propylene Glycol, Sorbitol, Dicalcium Phosphate, Sodium Lauryl Sulfate, Flavor, Urea Peroxide, Titanium Dioxide, Sodium Carbonate, Calcium Peroxide, Carbomer, Sodium Saccharin, Sodium Benzoate

QUESTIONS

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

Principal Display Panel -Tube 2.0 oz

Plus+White
Plus White  TOOTHPASTE with Peroxide

Net Wt 2.0 oz (56.6G) - Fluoride Anticavity Toothpaste

Principal Display Panel - Carton 2.0 oz

Plus + White 

Plus White Toothpaste with Peroxide

NET WT 2.0 oz (56.6G) Fluoride Anticavity Toothpaste 

INGREDIENTS AND APPEARANCE

PLUS WHITE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-1751
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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM CARBONATE (UNII: 45P3261C7T)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
SODIUM BENZOATE (UNII: OJ245FE5EU)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-1751-3	1 in 1 CARTON	05/22/2018
1		56.6 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	05/22/2018

Labeler - CCA Industries, Inc. (106771041)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(61543-1751)