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 Duane Reade, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEP

Sealed with printed neckband for your protection

Active ingredient

Eucalyptol 0.092%, Menthol 0.042%
Methyl salicylate 0.060%, Thymol 0.064%

Purpose

Antiginvitis, 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 Center right away.

Directions

adults and children 12 years 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 (59⁰-77⁰F)

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

ADVERSE REACTIONS

DISTRIBUTED BY DUANE READE

(866)375-6925

440 NINETH AVE, NY,NY 10001

duanereade.com

318.003/318AH

Principal Display Panel

UNIQUELY NY DR SINCE 1960

original

antiseptic mouthwash

kills germs that cause bad breath, plaque and the gum disease gingivitis

1.5 LITERS (50.7 FL OZ)

INGREDIENTS AND APPEARANCE

ORIGINAL ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67732-318
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	.092 kg  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.042 kg  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.060 kg  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	.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: 67732-318-86	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992
2	NDC: 67732-318-12	1.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992
3	NDC: 67732-318-77	.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992
4	NDC: 67732-318-69	.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992
5	NDC: 67732-318-13	1.2 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/15/1992

Labeler - Duane Reade (011988995)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(67732-318)