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Antiseptic Mouth Rinse by Western Family Foods, Inc.

Medically reviewed on January 1, 2018

Dosage form: mouthwash
Ingredients: EUCALYPTOL .092kg in 100L, MENTHOL .042kg in 100L, METHYL SALICYLATE .060kg in 100L, THYMOL .064kg in 100L
Labeler: Western Family Foods, Inc.
NDC Code: 55312-072

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.

Drug Facts

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

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 year 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 (59⁰-77⁰F)

Inactive ingredients water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow no. 10, FD+C green no.3

Sealed With Printed Neckband For Your Protection

The ADA Council on Scientific Affairs Acceptance of Western Family Spring Mint Antiseptic Mouth Rinse is based on its finding of the product is effective in helping 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
DSP-TN-15000
DSP-MP-34
SDS-TN-15012

WESTERN
FAMILY
ANTISEPTIC
Mouth Rinse
Kills Germs that
cause Bad breath,
Plaque + the gum
disease Gingivitis
Spring Mint
ADA
Accepted
American
Dental
Association
33.8 FL OZ
(1 QT 1.8 FL OZ)
1L
COMPARE TO THE ACTIVE
INGREDIENTS OF LISTERINE
ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-072
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL.042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (THYMOL) THYMOL.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
POLOXAMER 407 
BENZOIC ACID 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:55312-072-861 L in 1 BOTTLE, PLASTIC
2NDC:55312-072-77.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/14/1995
Labeler - Western Family Foods, Inc. (192166072)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture

 
Western Family Foods, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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