Tartar Control Plus: Package Insert and Label Information

TARTAR CONTROL PLUS- eucalyptol, menthol, methyl salicylate and thymol mouthwash
Rite Aid

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

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 yeard 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, sucralose, sodium saccharin, green 3

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, dstributor of Listerine Ultraclean With Everfresh Technology — Cool Mint.

Adverse Reactions

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

SATISFACTION

GUARANTEE

IF YOU’RE NOT SATISFIED, WE’LL

HAPPILY REFUND YOUR MONEY

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

855.000/855AA-AB

principal display panel

Sealed With Printed Neckband For Your Protection

RITE

AID

PHARMACY

Compare to Listerine

Ultraclean Cool Mint

tartar control plus

antiseptic

mouth rinse

antigingivitis/antplaque

blue mint

kills germs that cause bad

breath, plaque & the gum disease gingivitis

1 L (33.8 FL OZ)

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-5829 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 GREEN NO. 3

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:11822-5829-5 1000 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 02/09/2015

Labeler — Rite Aid (014578892)

Registrant — Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon		790752542	manufacture (11822-5829)

Revised: 09/2020 Rite Aid