ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

TEP

Sealed With Printed Neckband For Your Protection

active ingredent

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 serios form of gum disease.

stop use and ask a dentist if

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 ingredient

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodim citrate, D&C yellow no. 10, FD&C green no. 3

Questions

Call 1-888-593-0593

ADA Council Statement

The ADA Council on Scientific Affairs Acceptance of Meijer Fresh Mint Antiseptic Mouthwas is based on its finding tht the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed."

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, Distributor of Listerne

Adverse Reactions

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

072.002/072AL

principal display panel

NDC: 41250-072-86

Compare to FreshBurst Listerine active ingredients

meijer

Fresh Mint

Mouthwash

Antigingivitis/Antiplaque

Antiseptic

Kills germs that cause bad breath, plaque and gingivitis

ADA

Accepted

American

Dental

Association

33.8 FL OZ (1L)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-072
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	0.60 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)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-072-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/23/1996
2	NDC: 41250-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/23/1996
3	NDC: 41250-072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/23/1996
4	NDC: 41250-072-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/23/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/23/1996

Labeler - Meijer Distribution, Inc (006959555)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41250-072)