Otc - Active Ingredient
Active ingredient Purpose
Sodium Monofluorophosphate 0.884%
(0.15% w/v Fluoride ion).... Anticavity whitening toothpaste
Plus White Xtra Whitening
FDA Label NDC 61543-7243
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cca Industries, Inc. for the product Plus White Xtra Whitening (NDC 61543-7243). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Pluswhite Tube1 (Pluswhitetube1)
Plus White Box1 (Pluswhitebox1)
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