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Antiseptic by Hy-Vee Inc

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.6mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: Hy-Vee Inc
NDC Code: 42507-318

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

Safety Seal

SEALED WITH PRINTED NECKBAN FOR YOUR PROTECTION

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

use

Use helps control plaque that leads to gingivitis

Warnings

Warnings

Do not use

Don't use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediatel. These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist

Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of children

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

Directions

adults and chldren 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

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

Inactive ingredients

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

ADA Council Statement

The ADA Council on Scientific Affairs Acceptance of Hy-Vee original antiseptic mouth rinse is based on its finding that te product is effective in helping prevent and reduce gingivitis and plaqua above the gumlime, when used as directed.

Disclaimer

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine

Adverse Reaction

DISTRIBUTED BY HY-VEE, INC

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

SATISFACTION GUARANTEED

OR PURCHASE PRICE REFUNDED

FOR INFORMATION CALL

1-800-288-8343

Principal Display Panel

HyVee

Compare to the active

ingredients in Listerine

Oral Rinse

Antiseptic

Mouth rinse

Original

ADA

Accepted

American

Dental

Association

Kills germs that cause

bad breath, plaque & the

gum disease gingivitis

1.5 LITERS (50.7 FL OZ)

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-318
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 SALICYLATE0.6 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:42507-318-861000 mL in 1 BOTTLE, PLASTIC
2NDC:42507-318-121500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/15/1990
Labeler - Hy-Vee Inc (006925671)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(42507-318)

 
Hy-Vee Inc

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Medically reviewed on Sep 10, 2018

Further information

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

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