Tartar Control Plus: Package Insert and Label Information

TARTAR CONTROL PLUS- eucalyptol, menthol, methyl salicylate and thymol mouthwash
Kroger Co

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.

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

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.

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 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, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, blue 1

Questions or comments

1-800-632-6900

Disclaimer

Listerine is a registered trademark of Johnson & Johnson Healthcare Products,

New Brunswick, NJ 08903. Johnson & Johnson Healthcare Product is not affiliated with The Kroger Co. or this product

Adverse Reactions

DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OH 45202

DSP-TN-15000

DSP-M-34

SDS-TN-15012

434.000/434AB

principal display panel

COMPARE to the active ingredients of LISTERINE ULTRACLEAN WITH EVERFRESH TECHNOLOGY *See Back Label

Kroger

FROM OUR FAMILY TO YOURS

Mint

TARTAR CONTROL PLUS

ANTISEPTIC MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

Controls Tartar That Can Discolor Teeth

• Long Lasting Clean Feel
• Fights Bad Breath

1. Helps Prevent Plaque & Gingivitis

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

50.7 FL OZ (1.5 L)

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-434 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL MENTHOL (MENTHOL) MENTHOL 0.42 mg in 1 mL METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.60 mg in 1 mL THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID ZINC CHLORIDE SODIUM BENZOATE SUCRALOSE SACCHARIN SODIUM FD&C BLUE NO. 1

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:30142-434-12 1500 mL in 1 BOTTLE, PLASTIC None

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

Labeler — Kroger Co (006999528)

Registrant — Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon		790752542	manufacture (30142-434)

Revised: 09/2020 Kroger Co