ANTISEPTIC MOUTH RINSE - eucalyptol 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.

----------

Drug Facts

Eucalyptol 0.092%

Menthol 0.042%

Methyl sailcylate 0.060%

THYMOL 0.064%

Purpose
Antigingivitis

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

Compare to active ingredients
in Citrus Advanced Listerine
with Tartar Protection
Tartar Control
Antiseptic
Mouth Rinse
Citrus
•Helps fight tartar buildup
•Fights plaque + gingivitis
•Kills germs for extended plaque protection
•Enhanced breath protection
1.5 LITERS (50.7 FL OZ)
image of principal display panel
ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.092 kg  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.042 kg  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE0.060 kg  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-210-861 L in 1 BOTTLE, PLASTIC
2NDC:42507-210-121.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/22/2010
Labeler - Hy-Vee, Inc (006925671)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture

Revised: 4/2012
Document Id: 5585c3bc-f2d5-4710-89bc-94100ff0e79a
Set id: ffa8e29e-e905-4126-b85d-1b6d02a92937
Version: 2
Effective Time: 20120402
 
Hy-Vee, Inc