ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Western Family Foods, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antiseptic Mouthrinse
318.003/318AH

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

principal panel display

WESTERN FAMILY

ANTISEPTIC

MOUTH RINSE

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

ADA

Accepted

American Dental Association

COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-318
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/14/199604/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/14/199604/28/2022
Labeler - Western Family Foods, Inc. (192166072)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55312-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55312-318)

Revised: 6/2023
Document Id: db2a7b57-87b4-4b52-a25d-c13bd574d5f4
Set id: 38bbe6b4-d58a-4615-9f1b-614bc9e28db4
Version: 11
Effective Time: 20230609
 
Western Family Foods, Inc.