PLUS WHITE EXTRA WHITENING- sodium monofluorophosphate paste, 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 LLC, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Monofluorophosphate 0.83% (0.15% w/v fluoride ion)               

Purpose

Anticavity whitening toothpaste

Use

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

Warnings 

If more than used for brushing is accidentallly swallowed, get medical help or contact a  Poison Control Center  right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of 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
• to minimize swallowing for children under the age of 6, use a pea size amountandsupervisebrushinguntil good habitsare established
• children under 2 years of ask a dentistor physician

INACTIVE INGREDIENT

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

QUESTIONS

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

Plus White Extra Whitening -Carton 3.5 oz

Plus+White Extra Whitening 

Fluoride Protection

Fluoride Anticavity toothpaste

NET WT. 3.5 oz (100G)

Plus White Extra Whitening -Tube 3.5 oz

Plus +White Extra Whitening 

Fluoride Protection

NET WT 3.5 oz (100G)

INGREDIENTS AND APPEARANCE

PLUS WHITE EXTRA WHITENING 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-1502
Route of Administration	DENTAL

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)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
TRIBASIC SODIUM PHOSPHATE (UNII: A752Q30A6X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-1502-3	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 LLC (106771041)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(61543-1502)