ORIGINAL ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Original Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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 dentist immediately. 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 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

• 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 Publis Original Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduct gingivitis and plaque above the gumline, when used as directed

Safety seal

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Disclaimer

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

Adverse reaction

Distributed by:

Publix Super Markets, Inc

3300 Publix Corporate Parkway

Lakeland FL 33811

publis.com

PUBLIX GUARANTEE:

COMPLETE SATISFACTION OR YOUR MONEY BACK

Principal display panel

Publix

Original

ANTISEPTIC MOUTH RINSE

Kills germs that cause:

• bad breath
• plaque
• the gum disease Gingivitis

ADA

Accepted

American

Dental

Association

COMPARE TO THE ACTIVE

INGREDINTS OF LISTERINE

1 l (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ORIGINAL ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-318
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.092 kg  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.042 kg  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.060 kg  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.064 kg  in 100 L

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: 56062-318-86	1 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/11/1991

Labeler - Publix (006922009)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(56062-318)