ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antispetic by

Drug Labeling and Warnings

Antispetic by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc, Vi-Jon. 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

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

Other information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F)

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 Safeway 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 distribted by Johnson & Johnson Healthcare Products, distributor of Listerine

Adverse Reactions

Proudly dist. by Western Family Foods, Inc., P.O. Box 4057, Portland, OR 97208

www,westernfamily.com

664.002/664AS

Safety Sealed

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

principal display panel

WESTERN

FAMILY

ANTISEPTIC

Mouth Rinse

Kills Germs that

cause Bad Breath,

Plaque + the gum

disease Gingivitis

Blue Mint

ADA

Accepted

American

Dental

Association

COMPARE TO THE ACTIVE

INGREDIENTS OF LISTERINE

500 mL (16.9 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-664
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: 55312-664-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/1998
2	NDC: 55312-664-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/1998

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/15/1998

Labeler - Western Family Foods, Inc (192166072)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55312-664)