TARTAR CONTROL PLUS- eucalyptol, menthol, methyl salicylate, thymol mouthwash
C.D.M.A., 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.

----------

Quality Choice 326.000 326AE

Active ingredient

Eucalyptol .092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

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 under 12 yeard of age - consult a dentist or doctor

children under 6 years of age - do not use

this rinse is not intended to replace brushing or flossing

Inactive ingredients

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

Questions or comments?

1-248-449-9300 Weekdays 9 am - 4pm EST

Disclaimer

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

Adverse Reactions

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions:248-449-9300

326.000/326AE

principal display panel

QUALITY

CHOICE

Compare to LISTERINE

ULTRACLEAN With Everfresh Technology-Fresh Citrus

TARTAR

CONTROL

PLUS

Long Lasting Clean Feel

Antiseptic Mouth Rinse

Antigingivitis/Antiplaque

Kills germs that cause Bad Breath,

Plaque & the gum disease Gingivitis

Citrus Flavor

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

1 lITR (33.8 FL OZ)

image description

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-326
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-326-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/26/2013	06/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/26/2013	06/30/2020

Labeler - C.D.M.A., Inc (011920774)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(63868-326)

Revised: 6/2020

Document Id: a425d82d-7421-4725-8c74-2e7b48e2cf82

Set id: b3bc92b3-cc72-4b06-8b37-9828d89c3019

Version: 6

Effective Time: 20200630

C.D.M.A., Inc