PLUS WHITE XTRA WHITENING- sodium monofluorophosphate paste 
CCA Industries, Inc.

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

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

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

Package Labeling:

PlusWhiteBox1PlusWhiteTube1

PLUS WHITE XTRA WHITENING 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7243
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-7243-31 in 1 BOX06/11/2010
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/11/2010
Labeler - CCA Industries, Inc. (106771041)

Revised: 9/2020
Document Id: b00ec00f-3079-15a1-e053-2a95a90a879d
Set id: b3550c69-b79f-48e7-8d1e-85946a688de0
Version: 4
Effective Time: 20200924
 
CCA Industries, Inc.