PLUS WHITE XTRA- 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 Gel

Drug Facts

Active ingredient

Sodium Monofluorophosphate 0.83% (0.11% fluoride ion)

Purpose

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 burshing is accidentally swallowed, get medical helo or contact a Poison Control Center right away.

Directions

Inactive ingredients

Questions or comments?

call Toll Free 1-800-595-6230 • www.pluswhite.com

Package Labeling:

Label3

PLUS WHITE XTRA 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7237
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-7237-31 in 1 BOX03/15/2019
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: 8/2021
Document Id: b00eca8e-6e69-0975-e053-2a95a90a29f2
Set id: f10c9011-3731-45a9-a910-a690ad25df5f
Version: 5
Effective Time: 20210813
 
CCA Industries, Inc.