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Name:Antiseptic Rinse
Manufacturer:Meijer
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTISEPTIC RINSE  - eucalyptol, menthol, methyl salicylate and thymol mouthwash 
Meijer

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 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)

image of package label


ANTISEPTIC RINSE 
antiseptic mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-124
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-124-12 1.5 L in 1 BOTTLE, PLASTIC None
2 NDC:41250-124-86 1 L in 1 BOTTLE, PLASTIC None
3 NDC:41250-124-77 .5 L in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/08/2006

Labeler - Meijer (006959555)
Registrant - Vi Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon 790752542 manufacture

Revised: 05/2010 Meijer



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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