ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antispetic by

Drug Labeling and Warnings

Antispetic by is a Otc medication manufactured, distributed, or labeled by Big Lots, Vi-Jon, LLC. 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

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

• do not swallow
• not intended to replace brussing or flossing

adults and childen 12 years if age abd ikder - vigorously  swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth ttice a day for 30 seconds then spit out

children under 12 years of age - consult a dentist or doctor

other information

cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

Inactive ingredients

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

Questions or comments

1-888-593-0593

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of  Fresh Burst Listerine Antiseptic Mouthwash

Manufactured for Big Lots

By Vi-Jon, Inc

8515 Page Avenue

St. Louis, MO 63114

072.002/072AL

principal display panel

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Ingredients in Freshburst

Listerine Antiseptic

ANTISEPTIC

MOUTHRINSE

Antigingivitis/Antiplaque

Kills Germs That Cause:

• Plaque
• Bad Breath
• Gingivitis Gum Disease

SPRING MINT

1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ

INGREDIENTS AND APPEARANCE

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-072
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: 50594-072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2015
2	NDC: 50594-072-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/30/2015

Labeler - Big Lots (017885351)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(50594-072)