ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
Hy-Vee Inc

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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Hy Vee 318.002 318AH/AI

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

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 immediatel. 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 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

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

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

318.003/318AH

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)

image description

ANTISEPTIC
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-318
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
THYMOL (UNII: 3J50XA376E)	0.64 mg in 1 mL
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42507-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	08/15/1990	07/17/2020
2	NDC:42507-318-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/1990	07/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/1990	07/17/2020

Labeler - Hy-Vee Inc (006925671)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(42507-318)

Revised: 7/2020

Document Id: 8626f942-c2b4-4431-bd9e-45e3ae74c22c

Set id: e327866e-b997-4f7e-98e9-241c74c86685

Version: 10

Effective Time: 20200721

Hy-Vee Inc