ANTISEPTIC- eucalyptol, menthol, metyl salicylate, thymol rinse

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

TEP

Sealed with printed neckband for your protection

Active ingredients

Eucalyptol 0.092%, Menthol 0.042% Methy 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 serious 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

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 wealther 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 Equate Antiseptic Mouthrinse is based on its finding that the product is efective in helping to prevent and reduce gingivitis and plaque above the gum line, when used as directed"

Satisfaction  guaranteed

Or we'll replae it or give you your money back.  For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

Adverse Reactions section

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered mark Original Listerine

318.003/318AH

principal display panel

equate

Compare

to Original

Listerine

Active

Ingredients

Antiseptic

Mouthrinse

Kills Germs that Cause:

• Plaque
• Gingivitis
• Bad Breath

ADA

Accepted

American

Dental Association

Original

1.5 LITERS (50.7 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC  
eucalyptol, menthol, metyl salicylate, thymol rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-318
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	0.60 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)
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: 49035-318-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/1992
2	NDC: 49035-318-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/1992
3	NDC: 49035-318-21	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/1992
4	NDC: 49035-318-13	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/1992
5	NDC: 49035-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/27/1992

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(49035-318)