ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antispetic by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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 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 Acceptance of CVS/pharmacy Blue Mint Antiseptic Mouthwash is based on its finding that the product is effectie in helping to prevent and reduce gingivitis and plaque 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

DIST BY TOPCO ASSOCIATES LLC

7711 GROSS PROINT ROAD

SKOKIE, IL 60077

QUESTIONS? 1-888-423-0139

topcare@topco.com

664.002/664AS

Principal display panel

TOPCARE

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

BLUE MINT

Antiseptic

Mouth

Rinse

ADA

Accepted

American

Dental

Associatin

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

COMPARE TO LISTERINE

active ingredients

3.2 FL OZ (94 mL)

INGREDIENTS AND APPEARANCE

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-664
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: 36800-664-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992
2	NDC: 36800-664-19	94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992
3	NDC: 36800-664-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992
4	NDC: 36800-664-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992
5	NDC: 36800-664-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/26/1992

Labeler - Topco Associates LLC (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-664)