WHITENING FOAMING - sodium fluoride mouthwash 
Dio Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

active ingredients: sodium fluoride, allantoin

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

for dental care

keep out of reach of the children

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

store at room temperature

use when needed
dental use only

package label
WHITENING FOAMING 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75902-1001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.001 mL  in 1 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0005 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ETHANOLAMINE (UNII: 5KV86114PT)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75902-1001-150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/17/2010
Labeler - Dio Corporation (631085206)
Registrant - Dio Corporation (631085206)
Establishment
NameAddressID/FEIBusiness Operations
Dio Corporation631085206manufacture

Revised: 12/2010
Document Id: a07e92c3-0b69-4290-bac0-61651c32ac86
Set id: 419a65c2-73d4-49e0-a94e-4dd406b5958a
Version: 1
Effective Time: 20101217
 
Dio Corporation