PLUS WHITE EXTRA WHITENING- sodium monofluorophosphate gel, dentifrice

Plus White Extra Whitening by

Drug Labeling and Warnings

Plus White Extra 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 cavitites.

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 

•  Adults and children 2 years and older
•  Brush teeth thoroughly, after each meal, or at least twice a day, or as directed by a dentist or physician
• instruct under 6 years of age in good brushing and rinse habits (it minimizes swallowing), and only use a pea size amount.
• Children under 2 years ask a dentist or physician

INACTIVE INGREDIENT

Inactive ingredients Sorbitol, Hydrated Silica, Glycerin, Water (Purified), PEG 32, Flavor, Sodium lauryl Sulfate, PVM/MA Copolymer, Flavor, Cellulose Gum, Trisodium Phosphate, Sodium Phosphate, Sodium Saccharin, Blue 1, yellow 10

QUESTIONS

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

Principal Display Panel -Tube 3.5 oz

Plus+White
Extra Whitening Gel TOOTHPASTE

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

Principal Display Panel - Carton 3.5 oz

Plus + White 

Extra Whitening Gel Toothpaste 

NET WT 3.5 oz (100G) Fluoride Anticavity Toothpaste 

INGREDIENTS AND APPEARANCE

PLUS WHITE EXTRA WHITENING 
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-1606
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)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

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: 61543-1606-3	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(61543-1606)