ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

active ingredient

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Stop use and ask a dentist if

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen guns, pus fro the gum line, loose teeth or increased spacing between the teeth.  These may be signs of periodontitis, a serious form of gum disease.

Keep out of reach of children under  6 years of age.  If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

Keep out of reach of children under 6 years of age. 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 teaspoonsful) between your teeth twice a day for 30 seconds then spit out.  Do not swallow the rinse.
• children 6 years to under 12 years of age: supervise use
• children under 6 years of age: do not use

Other information

• this rinse is not intended to replace brushing or flossing
• cold weather may cloud this product.  Its antiseptic properties are not affected.

Store at room temperatures (59⁰-77⁰F)

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sucralose and/or sodium saccharin, sodium benzoate, propylene glycol alginate, FD&C yellow no. 6, FD&C blue no. 1

TEP

Sealed With Printed Neckband For Your Protection

principal display panel

vanilla mint

antiseptic mouthwash

for fresher breath

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

1 liter 33.8 fl oz

INGREDIENTS AND APPEARANCE

ANTISEPTIC  
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67732-124
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 BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67732-124-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2006
2	NDC: 67732-124-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/08/2006

Labeler - Duane Reade (011988995)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(67732-124)