PLUS WHITE COFFEE DRINKERS 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.

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Plus White Coffee Drinkers Whitening

Drug Facts

Active ingredients

Sodium Monofluorophosphate (0.15% w/v fluoride ion)

Purpose

Anticavity whitening toothpaste

Use

Aids in the removal of stains and prevention of dental decay.

Warnings

 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.

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

Sorbitol, Water (Aqua), Hydrated Silica, Dicalcium Phosphate, Glycerin, Sodium Lauryl Sulfate, PVM/MA Copolymer, Flavor, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin.

Questions or comments?

Call Toll Free1-800-595-6230 - www.pluswhite.com

Package Labeling:

PlusWhiteCoffee-BoxPlusWhiteCoffee-Tube

PLUS WHITE COFFEE DRINKERS WHITENING 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7224
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
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-7224-31 in 1 PACKAGE06/12/2010
1100 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/12/2010
Labeler - CCA Industries, Inc. (106771041)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(61543-7224)

Revised: 9/2020
Document Id: b0005220-427b-98f6-e053-2995a90adea0
Set id: 3687ebb3-be4a-4e46-8f1d-dcf56fddcdfa
Version: 4
Effective Time: 20200923
 
CCA Industries, Inc.