PLUS WHITE WITH PEROXIDE- sodium monofluorophosphate paste

Plus White With Peroxide by

Drug Labeling and Warnings

Plus White With Peroxide by is a Otc medication manufactured, distributed, or labeled by CCA Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fatcs

Active ingredient

Sodium Monofluorophosphate 0.83% (0.11% w/v fluoride ion)                               

Purpose

Anticavity whitening toothpaste

Use

aids in the prevention of dental cavities

WARNINGS

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
• b rush 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:

GLYCERIN, HYDRATED SILICA, PROPYLENE GLYCOL, SORBITOL, DICALCIUM PHOSPHATE, SODIUM LAURYL SULFATE, FLAVOR, UREA PEROXIDE, TITANIUM DIOXIDE, SODIUM CARBONATE, CALCIUM PEROXIDE, CARBOMER, SODIUM SACCHARIN, SODIUM BENZOATE.

Questions or comments?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

PLUS WHITE WITH PEROXIDE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-7233
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM CARBONATE (UNII: 45P3261C7T)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-7233-2	1 in 1 BOX	03/15/2019
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/09/2010

Labeler - CCA Industries, Inc. (106771041)