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Name:Antiseptic Mouth Rinse
Manufacturer:Hy-vee, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTISEPTIC MOUTH RINSE  - eucalyptol, menthol, methyl salicylate and thymol mouthwash 
Hy-Vee, 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

Eucalyptol 0.092%

Menthol 0.042%

Methyl sailcylate 0.060%

THYMOL 0.064%

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

adults and children 12 years
of age and older - vigorously swish20 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 (59⁰- 77⁰F)

Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40

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

DISTRIBUTED BY HY-VEE, INC

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

SATISFACTION GUARANTEED

OR PURCHASE PRICE REFUNDED

FOR INFORMATON CALL

1-800-289-8343

www.hy-vee.com

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Sealed With Printed Neckband For Your Protection
COMPARE TO CITRUS ADVANCED LISTERINE WITH TARTAR PROTECTION
HY-VEE
FIGHTS TARTAR BUILD-UP BETTER
THAN BRUSHING ALONE
ANTISEPTIC
MOUTH RINSE
TARTAR CONTROL

•helps fight tartar buildup

•Fights plaque + gingivitis

•Kills germs for extended plaque protection

•Enhanced breath protection

CITRUS

1 LITER (33.8 FL OZ)
image of principal display panel


ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-210
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL 0.042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 0.060 kg  in 100 L
THYMOL (THYMOL) THYMOL 0.064 kg  in 100 L
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
SORBITOL  
POLOXAMER 407  
BENZOIC ACID  
ZINC CHLORIDE  
SUCRALOSE  
SODIUM BENZOATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42507-210-86 1 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 07/22/2010

Labeler - Hy-Vee, Inc (006925671)
Registrant - Vi Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon 790752542 manufacture

Revised: 09/2010 Hy-Vee, Inc



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


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