Tartar Control

Dosage form: mouthwash
Ingredients: EUCALYPTOL .092mL in 100L, MENTHOL .042mL in 100L, METHYL SALICYLATE .060mL in 100L, THYMOL .064mL in 100L
Labeler: Western Family
NDC Code: 55312-210

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 0.024%
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 guns, 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 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 propertied 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
DSP-TN-15000
DSP-MO-34
SDS-TN-15012

WESTERN
FAMILY
Antiseptic Mouthwash
TARTAR
CONTROL
Helps Control tartar
helps remove Germs That Cause Plaque and Gingivitis
Freshens Breath
Brightens Teeth
Citrus
COMPARE TO THE ACTIVE
INGREDIENTS OF LISTERINE
1 L (33.8 FL OZ)
TARTAR CONTROL 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL.092 mL  in 100 L
MENTHOL (MENTHOL) MENTHOL.042 mL  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE.060 mL  in 100 L
THYMOL (THYMOL) THYMOL.064 mL  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
POLOXAMER 407 
BENZOIC ACID 
ZINC CHLORIDE 
SUCRALOSE 
SODIUM BENZOATE 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:55312-210-861 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/23/2010
Labeler - Western Family (192166072)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture

Revised: 03/2012
 
Western Family

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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