FDA Label for Plus White Xtra Whitening
View Indications, Usage & Precautions
Plus White Xtra Whitening Product Label
The following document was submitted to the FDA by the labeler of this product Cca Industries, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Purpose
Sodium Monofluorophosphate 0.884%
(0.15% w/v Fluoride ion).... Anticavity whitening toothpaste
Otc - Purpose
Use Aids in the prevention of dental cavities and removal of stains.
Otc - Keep Out Of Reach Of Children
Warnings - 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.
Dosage & Administration
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 Ingredient
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).
Otc - Questions
Questions or comments? Call Toll Free 1-800-595-6230 - www.pluswhite.com
Package Label.Principal Display Panel
For best results squeeze tube from bottom Net Wt 3.5 oz/100gPlus WhiteDOUBLE ACTION STAIN REMOVERSEVERYDAY WHITENING TOOTHPASTE WITH FLUORIDEXTRAWHITENINGCool Mint FlavorXTRA Whitening for Whiter,Brighter Teeth, Fast!Specially Formulated to Remove:- Coffee - Tea- Wine - Tobaccoand Other Food Stains!Helps Remove Plaque to Control TartarFights CavitiesActive ingredient Sodium Monofluorophosphate 0.884% (0.15% w/v Fluoride ion)Use Aids in the prevention of dental cavities and removal of stains.Warnings Keep out of the reach of children under 6 years of age - In case of accidentalingestion, seek professional assistance or contact a Poison Control Center immediately.Directions - Adults and children 2 years and older: brush teeth thoroughly after meals orat least twice a day, or as directed by a dentist or physician - To minimize swallowing forchildren under 6, use a peasized amount and supervise brushing until good habits areestablished - Children under 2 years: Consult a dentist or physician.Dist. by: CCA Industries, Inc., E. Rutherford, NJ 07073 USA27243X-03-3C PW-H-NAQuestions or comments?Call Toll Free 1-800-595-6230 - www.pluswhite.com
EVERY DAY WHITENING TOOTHPASTEWith Tartar ControlPlus WhiteDOUBLE ACTION STAIN REMOVERSNet Wt 3.5 oz/100g Fluoride ProtectionXTRAWHITENINGCool Mint PasteSpecially Formulatedto Remove:CoffeeTeaWineTobaccoand Other Tough Stains!Plus WhitePlus WhiteXTRAWHITENING
* Please review the disclaimer below.