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Name:Antiseptic Mouth Rinse
Manufacturer:Western Family Foods, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTISEPTIC MOUTH RINSE  - eucalyptol, menthol, methyl salicylate and 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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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
image of principal display panel

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-072
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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 Name Strength
WATER  
ALCOHOL  
POLOXAMER 407  
BENZOIC ACID  
D&C YELLOW NO. 10  
FD&C GREEN NO. 3  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55312-072-86 1 L in 1 BOTTLE, PLASTIC None
2 NDC:55312-072-77 .5 L in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/14/1995

Labeler - Western Family Foods, Inc. (192166072)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon 790752542 manufacture

Revised: 01/2011 Western Family Foods, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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