PLUS WHITE XTRA WHITENING- sodium monofluorophosphate paste

Plus White Xtra Whitening by

Drug Labeling and Warnings

Plus White Xtra Whitening by is a Otc medication manufactured, distributed, or labeled by CCA Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Monofluorophosphate 0.884% (0.15% w/v Fluoride ion)                   

Purpose

Anticavity whitening toothpaste

​Use

   Aids in the prevention of dental cavities and removal of stains

Warnings

- 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

• 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 6, use a pea-sized amount and supervise brushing until good habits are established
• children under 2 years ask a dentist or physician.

Inactive ingredients

Hydrated Silica, Sorbitol, Water (Aqua), Dicalcium Phosphate, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Titanium  Dioxide, 

Trisodium Phosphate, PVM/MA Copolymer, Sodium Saccharin, Blue 1 (CI 42090).

QUESTIONS

Questions or comments? Call Toll Free 1-800-595-6230 - www.pluswhite.com

Package Labeling:

INGREDIENTS AND APPEARANCE

PLUS WHITE XTRA WHITENING 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-7243
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
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-7243-3	1 in 1 BOX	06/11/2010
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	06/11/2010

Labeler - CCA Industries, Inc. (106771041)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead, Inc.		078584069	manufacture(61543-7243)