Tartar Control (Eucalyptol) Mouthwash [Western Family] -

TARTAR CONTROL (EUCALYPTOL) MOUTHWASH [WESTERN FAMILY]
PDF | XML

NDC	55312-210-86
Set ID	454cafaa-4793-43af-b6a4-dbcc25112cf0
Category	HUMAN OTC DRUG LABEL
Packager	Western Family
Generic Name
Product Class
Product Number
Application Number	PART356

View All Sections

ACTIVE INGREDIENT

Active ingredients
Eucalyptol 0.092% Menthol 0.024%
Methyl salicylate 0.060% thymol 0.064%

Purpose
Antigingivitis, Antiplaque
INDICATIONS & USAGE

Use helps control plaque that leads to gingivitis
WARNINGS

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.
DOSAGE & ADMINISTRATION

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
STORAGE AND HANDLING

Other information cold weather may cloud this product. Its antiseptic propertied are not affected. Store at room temperature (59⁰-77⁰F).
INACTIVE INGREDIENT

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
SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine
DSP-TN-15000
DSP-MO-34
SDS-TN-15012
PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

TARTAR CONTROL
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-210
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	.092 mL in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.042 mL in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	.060 mL in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	.064 mL in 100 L

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-210-86	1 L in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	09/23/2010

Labeler - Western Family (192166072)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture

View All Sections

Medic

TARTAR CONTROL (EUCALYPTOL) MOUTHWASH [WESTERN FAMILY]

Related Drugs