WHITENING FOAMING-TOOTHPASTE- sodium fluoride gel, dentifrice

Whitening Foaming-Toothpaste by

Drug Labeling and Warnings

Whitening Foaming-Toothpaste by is a Otc medication manufactured, distributed, or labeled by Dio Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredients: sodium fluoride, allantoin

INACTIVE INGREDIENT

inactive ingredients: ethanol sodium lauryl sulfact, xylitol, sodium saccharin, ginger, mugwort extract, cnidium extract, mint, methylparaben, water

PURPOSE

for dental care

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

brush teeth with your tooth brush or gargle after spraying it into your mouth

WARNINGS

store at room temperature

DOSAGE & ADMINISTRATION

use when needed
dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHITENING FOAMING-TOOTHPASTE 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75902-2001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.001 mL  in 1 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.0005 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
GINGER (UNII: C5529G5JPQ)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
MINT (UNII: FV98Z8GITP)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75902-2001-1	50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/04/2011

Labeler - Dio Corporation (631085206)

Registrant - Dio Corporation (631085206)

Establishment
Name	Address	ID/FEI	Business Operations
Dio Corporation		631085206	manufacture