PLUS WHITE XTRA- sodium monofluorophosphate paste

Plus White Xtra by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

• adults and children 2 years and older
• brush 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

Questions or comments?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

PLUS WHITE XTRA 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-7237
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-7237-3	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 final	part355	06/11/2010

Labeler - CCA Industries, Inc. (106771041)