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Antiseptic Mouth Rinse by WinCo Foods, LLC

Medically reviewed on April 25, 2018

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.60mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: WinCo Foods, LLC
NDC Code: 67091-106

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.


Drug Facts

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

For this product

Do not use

If you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist

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

Keep out of reach of children

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 for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

Other information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Questions

Or to report and adverse event call 800-824-1706

Monday - Friday 9am - 4 pm MST

ADA Council Statement

The ADA Council on Scientific Affairs Acceptance of WinCo Foods Original Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

Disclaimer

This product is manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Original LISTERINE Antiseptic Mouthwash

Adverse reaction

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

318.003/318AH

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Compare to the active ingredients in

Original LISTERINE Antiseptic Mouthwash

WinCo

FOODS

ANTISEPTIC

Mouth Rinse

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Kills Germs Tht Cause Bad Breath,

Plaque and Gingivitis Gum Disease

For Better Oral Hygiene and Fresher Breath

ADA

Accepted

American

Dental

Association

Original

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
BENZOIC ACID 
POLOXAMER 407 
SODIUM BENZOATE 
CARAMEL 
Packaging
#Item CodePackage Description
1NDC:67091-106-331000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/03/2014
Labeler - WinCo Foods, LLC (056098817)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(67091-106)

 
WinCo Foods, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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