ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Hy-Vee Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-318-86	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 42507-318-12	1500 mL in 1 BOTTLE, PLASTIC

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

Labeler - Hy-Vee Inc (006925671)

Registrant - Vi-Jon (790752542)

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