VORTEX- toothpaste paste, dentifrice

Vortex by

Drug Labeling and Warnings

Vortex by is a Otc medication manufactured, distributed, or labeled by DSC Laboratories, Div. of DSC Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sodium Fluoride 0.20%

Purpose

Anticavity

Use

Aids in prevention of dental decay.

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

• Twist off cap and remove foil seal
• Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist.
• Do not swallow
• To minimize swallowing use a pea-sized amount in children under 6.
• Supervise children's brushing until good habits are established.
• Children under 2 yrs.: ask a dentist

Inactive Ingredients

Purified water, Glycerin, Xylitol, Hydrated Silica, Carbomer Homopolymer Type C, Natural Grape Flavor, Xanthan Gum, D and C Red #28, FD and C Blue #1, D and C Red #33.

Questions?

Call 1-314-436-3332

VORTEX TOOTHPASTE 120G TUBE

Vortex Anti-Cavity Fluoride  Toothpaste

Net Wt. 4.2 oz (120g)

Distributed by: Wright Toothpaste Inc.

St. Louis, MO 63127

INGREDIENTS AND APPEARANCE

VORTEX 
toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52316-028
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
XANTHAN GUM (UNII: TTV12P4NEE)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52316-028-42	120 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/30/2011

Labeler - DSC Laboratories, Div. of DSC Products Inc. (097807374)

Establishment
Name	Address	ID/FEI	Business Operations
DSC Laboratories, Div. of DSC Products Inc.		097807374	manufacture