Antiseptic Rinse

Dosage form: mouthwash
Ingredients: EUCALYPTOL .092kg in 100L, MENTHOL .042kg in 100L, METHYL SALICYLATE .060kg in 100L, THYMOL .064kg in 100L
Labeler: Meijer
NDC Code: 41250-124

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.

Drug Facts

Active Ingredient                                  Purpose

Eucalyptol 0.092%                                Antigingivitis, Antiplaque

Menthol 0.042%                                   Antigingivitis, Antiplaque

Methyl salicylate 0.060%                      Antigingivitis, Antiplaque

Thymol 0.064%                                    Antigingivitis, Antiplaque


Use helps control plaque that leads to gingivitis

Stop use and ask a dentist if

•gingivitis, bleeding, or redness persists for more than 2 weeks

•you have painful or swollen guns, pus from the gun line, loose teeth or increased spacing between the teeth.  These may be signs of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.  If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

•adults and children 12 years of age and older: vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out.  Do not swallow the rinse.

•children 6 years to under 12 years of age: supervise use

•children under 6 years of age: do not use

Other information

•this rinse is not intended to replace brushing or flossing

•cold weather may cloud this product. Its antiseptic properties are not affected.  Store at room temperature (59⁰- 77⁰ F).

Inactive ingredients water, alcohol 21.6%), sorbitol solution, flavor, poloxamer 407, benzoic acid, sucralose and/or sodium saccharin, sodium benzoate, propylene glycol alginate, FD+C yellow no.6, FD+C blue no. 1

Antiseptic

Mouth Rinse

Kills germs that cause bad breath, palque + the gum disease gingivitis

Vanilla Mint

50.7 FL OZ (1.5 L)

ANTISEPTIC RINSE 
antiseptic mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-124
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL.042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (THYMOL) THYMOL.064 kg  in 100 L
Packaging
#Item CodePackage Description
1NDC:41250-124-121.5 L in 1 BOTTLE, PLASTIC
2NDC:41250-124-861 L in 1 BOTTLE, PLASTIC
3NDC:41250-124-77.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/08/2006
Labeler - Meijer (006959555)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture

Revised: 05/2010
 
Meijer

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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