VENUS WHITE CLEAN MINT WHITENING- sodium fluoride paste, dentifrice
Heraeus Kulzer LLC

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.

----------

Venus White® Clean Mint Whitening Toothpaste

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.

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

Principal Display Panel - 28.35 g Tube Carton

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	05/01/2012	08/31/2020

Labeler - Heraeus Kulzer LLC (838274058)

Revised: 1/2020

Document Id: 9185a531-a8fa-4489-b224-6413a844b0e3

Set id: 41723f98-72a5-400a-a04b-b3ade1391ead

Version: 3

Effective Time: 20200116

Heraeus Kulzer LLC