Plus White Xtra
FDA Label NDC 61543-7237

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 (NDC 61543-7237). 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, description, 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 - 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 Sorbitol, Hydrated Silica, Glycerin, Water (Aqua), Peg-32,Sodium Lauryl Sulfate, Cellulose Gum, Trisodium Phosphate, Flavor, Sodium Phosphate,PVM/MA Copolymer, Sodium Saccharin, Blue 1 (CI 42090), Yellow 10 (CI 47005).

Otc - Questions

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

Description

Plus White

XTRA
WHITENING gel

#27237-01F

Double Action Stain Removers
Polish Away Tough Stains

Helps Remove Plaque
to Control Tartar

Leaves Your Whole Mouth
Feeling Fresh and Clean

COFFEE  WINE  TOBACCO

XTRA Whitening for Whiter, Brighter Teeth, Fast!

Plus White’s state-of-the-art double action stain removers work like no ordinary
toothpaste to remove coffee, tea, tobacco, wine and other food and surface stains.
The result? Your teeth will look shades whiter and brighter. Guaranteed.
Plus White toothpaste also helps remove plaque to control tartar.
In addition, the fluoride works to protect your teeth against cavities, while the
long-lasting minty taste leaves your mouth feeling refreshed every time you brush.

Contains no animal fat.

MONEY BACK GUARANTEE
SEE BOTTOM OF BOX FOR DETAILS.

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 gelXTRA 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 (0.15% w/v fluoride ion) Use Aids inthe prevention of dental cavities and removal of stains Warnings - Keep out of the reach ofchildren under 6 years of age - In case of accidental ingestion, seek professional assistanceor contact a Poison Control Center immediately Directions - Adults and children 2 yearsand older: brush teeth thoroughly after meals or at least twice a day, or as directed by adentist or physician - To minimize swallowing for children under 6, use a pea-sizedamount and supervise brushing until good habits are established - Children under 2 years:Consult a dentist or physician.Dist. by: CCA Industries, Inc., E. Rutherford, NJ 07073 USA27237-03-3A                    PW-L-NEQuestions or comments?Call Toll Free 1-800-595-6230 - www.pluswhite.com

EVERYDAY WHITENING TOOTHPASTEPlus WhiteDOUBLE ACTION STAIN REMOVERSNet Wt 3.5 oz/100g         Fluoride ProtectionXTRAWHITENING Cool Mint gelSpecially Formulatedto Remove:CoffeeTeaWineTobaccoand Other Tough Stains!Plus WhitePlus WhiteXTRAWHITENING

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