ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antispetic by

Drug Labeling and Warnings

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

Drug Details [pdf]

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active Ingredients

Eucalyptol 0.0692%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help 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

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 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

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

ADA Council Statement

The ADA Council on scientific affairs Acceptanc of Swan Blue Mint Antiseptic mouth rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plque above the gumline, when used as directed

Disclaimer

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

Adverse Reactions

Distributed by: Vi-Jon, Inc

One Swan Drive, Smyrna, TN 37167

664/002/664AS

principal display panel

Meets current TSA's guidelines for carry-on luggage

Swan

ANTISEPTIC

MOUTH RINSE

ice mint

Kills Germs that

Cause Bad Breath

Plaque & the Gum mm1.jpg

Disease Gingivitis

Compare to active ingredients

of Listerine

Sealed with printed neckband for your protection

3.2 FL OZ (94 mL)

principal display panel

mountain

falls

Compare

to Listerine

improves

oral

hygiene

kills germs

that cause bad

breath, plaque

and gingivitis

gum disease

for

daily

mouth

care

freshens

breath

antiseptic

mouth rinse

antiseptic

mouth rinse

antigingivitis/antiplaque

blue mint

1.5 L (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: 0869-0664
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)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0664-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1992
2	NDC: 0869-0664-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1992
3	NDC: 0869-0664-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1992
4	NDC: 0869-0664-88	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1992
5	NDC: 0869-0664-13	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1992
6	NDC: 0869-0664-12	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1992
7	NDC: 0869-0664-19	94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/15/1992

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0869-0664)