Plus White Xtra Whitening

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.884g in 100g
Labeler: CCA Industries, Inc.
NDC Code: 61543-7243

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Plus White Xtra Whitening

Active ingredient                                                                      Purpose
Sodium Monofluorophosphate 0.884%
(0.15% w/v Fluoride ion)....                             Anticavity whitening toothpaste

Use Aids in the prevention of dental cavities and removal of stains.

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.

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

For best results squeeze tube from bottom        Net Wt 3.5 oz/100g

Plus White
DOUBLE ACTION STAIN REMOVERS

EVERYDAY WHITENING TOOTHPASTE WITH FLUORIDE

XTRA
WHITENING

Cool Mint Flavor

XTRA Whitening for Whiter,
Brighter Teeth, Fast!
Specially Formulated to Remove:
- Coffee - Tea
- Wine - Tobacco
and Other Food Stains!
Helps Remove Plaque to Control Tartar
Fights Cavities

Active 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 accidental
ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions - Adults and children 2 years and older: brush teeth thoroughly after meals or
at least twice a day, or as directed by a dentist or physician - To minimize swallowing for
children under 6, use a peasized amount 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 USA
27243X-03-3C         PW-H-NA

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

EVERY DAY WHITENING TOOTHPASTE

With Tartar Control

Plus White
DOUBLE ACTION STAIN REMOVERS

Net Wt 3.5 oz/100g        Fluoride Protection

XTRA
WHITENING

Cool Mint Paste

Specially Formulated
to Remove:
Coffee
Tea
Wine
Tobacco
and Other Tough Stains!

Plus White

Plus White

XTRA
WHITENING

PLUS WHITE XTRA WHITENING 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7243
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (SODIUM CATION) SODIUM MONOFLUOROPHOSPHATE0.884 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA 
SORBITOL 
WATER 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
GLYCERIN 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
TITANIUM DIOXIDE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:61543-7243-31 TUBE (TUBE) in 1 BOX
1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33306/11/2010
Labeler - CCA Industries, Inc. (106771041)
Establishment
NameAddressID/FEIOperations
Lornamead, Inc.126440440manufacture

Revised: 06/2010
 
CCA Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)