TARTAR CONTROL PLUS- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Tartar Control Plus by

Drug Labeling and Warnings

Tartar Control Plus by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

for this product

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 twice a day for 30 second then spit out; do not swallow

children 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

• 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 (59° - 86° F)

Inactive ingredients

water, alcohol (21.6%), sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucraloe, PEG-40 hydrogenated castor oil, yellow 6, red 40

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Ultraclean With Everfresh Technology-Fresh Citrus.

Adverse Reactions

Distribted by Topco Associates LLC

Elk Grove Village, IL 60007

1-888-423-0139

topcare@topco.com

326.000/326AA

principal display panel

TOPCARE

Sealed With Printed Neckband For Your Protection

CITRUS

Tartar Control

PLUS

Antiseptic Mouth Rinse

Antigingivitis/Antiplaque

Kills germs that cause Bad Breath, Plaque & the gum disease Gingivitis

Long Lasting clean feel

Helps fight tartar buildup

COMPARE TO LISTERINE ULTRACLEAN

With Everfresh Technology-Fresh Citrus

3.8 FL OZ (1 QT 1.8 FL OZ ) 1 L

INGREDIENTS AND APPEARANCE

TARTAR CONTROL PLUS 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-941
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ZINC CHLORIDE (UNII: 86Q357L16B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-941-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2013
2	NDC: 36800-941-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/01/2013

Labeler - Topco Associates LLC (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-941)