ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic Mouth Rinse by

Drug Labeling and Warnings

Antiseptic Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc., 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 0.034%

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

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 a 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 (59⁰ - 77⁰ F)

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

disclaimer

The ADA Council on Scientific Affairs Acceptance of Western Family Antiseptic Mouth Rinse is based on its finding that the product is
effective to prevent and reduce gingivitis and plaque above the gumline, when used as directed

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

Adverse reactions

Proudly Distributed by

Western Family Foods, Inc. 

P.O. Box 4057

Portland, OR 97208 USA

www. westernfamily.com

318.003/AH

Principal display panel

WESTERN FAMILY

ANTISEPTIC

Mouthm Rinse

Kills Germs that cause Bad Breath, Plaque & the gum disease Gingivitis

COMPARE TO THE ACTIVE

INGREDIENTS OF LISTERINE

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-318
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	.092 kg  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.042 kg  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.060 kg  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	.064 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-318-86	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/14/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/14/1996

Labeler - Western Family Foods, Inc. (192166072)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55312-318)