VENUS WHITE CLEAN MINT WHITENING- sodium fluoride paste, dentifrice

Venus White by

Drug Labeling and Warnings

Venus White by is a Otc medication manufactured, distributed, or labeled by Heraeus Kulzer LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sodium Fluoride 0.25%w/w

Purpose

Anticavity

Use

Aids in the prevention of dental decay.

Warning

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 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 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Glycerin, Water (aqua), Silica, Sorbitol, Xylitol, Flavor (aroma), Poloxamer, Sodium Lauryl Sulfate, Carbomer, FD&C Blue #1 (CI 42090), Sodium Benzoate, Sodium Hydroxide, Sparkle (CI 77019, CI 77891), Sucralose, and Xanthan Gum.

SPL UNCLASSIFIED SECTION

Distributed by:
Kulzer, LLC
4315 South Lafayette Blvd.
South Bend, IN 46614-2517

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

Venus White®

Clean Mint
NET WT 1.0 OZ (28.35 g)

Whitening Toothpaste
WITH FLUORIDE AND XYLITOL

INGREDIENTS AND APPEARANCE

VENUS WHITE   CLEAN MINT WHITENING
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62566-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sorbitol (UNII: 506T60A25R)
Xylitol (UNII: VCQ006KQ1E)
Methyl Salicylate (UNII: LAV5U5022Y)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Hydroxide (UNII: 55X04QC32I)
Sucralose (UNII: 96K6UQ3ZD4)
Xanthan Gum (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62566-001-01	1 in 1 BOX	05/01/2012	08/31/2020
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 62566-001-02	1 in 1 BOX	05/01/2012	08/31/2020
2		28.35 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	05/01/2012	08/31/2020

Labeler - Heraeus Kulzer LLC (838274058)