PLUS WHITE PLUS EVERY DAY WHITENING- sodium monofluorophosphate paste, dentifrice
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 Plus EVERY DAY WHITENING TOOTHPASTE

Drug Facts

Active ingredient

Sodium monofluorophosphate 1.14% (0.19% w/v 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 the used for brushing in accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good
brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Inactive ingredients

sorbitol, water (aqua), hydrated silica, glycerin, sodium hexametaphosphate, dicalcium phosphate, PVP, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, sodium saccharin, blue 1 (CI 42090)

Questions or comments?

Call Toll Free 1-800-595-6230

www.PlusWhite.com

Product Labels

Inner Label Outer Label

PLUS WHITE PLUS EVERY DAY WHITENING
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61543-7254
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.14 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61543-7254-3	1 in 1 CARTON	08/01/2013	09/30/2015
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/01/2013	09/30/2015

Labeler - CCA Industries, Inc. (106771041)

Revised: 3/2019

Document Id: 848d7654-d19a-1d88-e053-2a91aa0ad5a5

Set id: 0149d472-1bc9-40c4-9ffc-9323e193a49e

Version: 3

Effective Time: 20190320

CCA Industries, Inc.