ANTISPETIC- 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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Western Family 664.003 664AU

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)

image description

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-664
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-664-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/199805/20/2021
2NDC:55312-664-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/199805/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/15/199805/20/2021
Labeler - Western Family Foods, Inc (192166072)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55312-664)

Revised: 5/2021
 
Western Family Foods, Inc