ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate and thymol mouthwash 
Kroger Co

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.

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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 periodtitis, 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 chrildren

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 comments?

1-800-632-6900

ADA Council Statement

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

Disclaimer

Listerine is a registered trademark of Johnson & Johnson Healthcare Products, New Brunswick, NJ 08903.  Johnson & Johnson Healthcare Products is ot affiliated wth The Kroger Co. or this product.

Adverse reaction

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

800-632-6900   www.kroger.com

principal display panel

COMPARE to the active ingredients of ORIGINAL LISTERINE

KROGER

FROM OUR FAMILY TO YOURS

Original

ANTISEPTIC

MOUTHRINSE

ANTIGINGIVITIS/ANTIPLAQUE

  • Kills Germs That Cause Bad Breath, Plaque & the Gum Disease Gingivitis
  • For Fresher Breath

ADA

Accepted

American

Dental

Associatin

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

16.9 FL OZ (500 mL)

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-318
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 DescriptionMarketing Start DateMarketing End Date
1NDC:30142-318-861000 mL in 1 BOTTLE, PLASTIC
2NDC:30142-318-77500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/1991
Labeler - Kroger Co (006999528)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(30142-318)

Revised: 4/2014
 
Kroger Co