Tartar Control Plus: Package Insert and Label Information

TARTAR CONTROL PLUS- eucalyptol, menthol, methyl salicylate and thymol mouthwash
Foodhold U.S.A., LLC

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 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

Disclaimer

This product is not manufactured or distribted by Johnson & Johnson Healthcare Products, distributor of Listerine Ultraclean with Everfresh Technology — Artic Mint.

Adverse Reactions

DISTRIBUTED BY

FOODHOLD U.S.A.,LLC

LANDOVER, MD 20785

1-877-846-9949

2013 S&S Brands, LLC

Quality guaranteed or money back

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

434.000/434AA-AB

principal display panel

Compare to Listerine Ultraclean With Everfresh Technolog-Arctic Mint

CARE ONE

TARTAR CONTROL

PLUS

ANTISEPTIC

MOUTH RINSE

Antigingivitis/Antiplaque

ICEBERG BLUE FLAVOR

  • Helps fight tartar buildup
  • Long Lasting clean feel
  • Kills germs that cause Bad Breath, Plaque & the gum disease Gingivitis

1 LITER

(33.8 FL OZ)

image description
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TARTAR CONTROL PLUS
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-434
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:41520-434-86 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 09/06/2013
Labeler — Foodhold U.S.A., LLC (809183973)
Registrant — Vi-Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon 790752542 manufacture (41520-434)

Revised: 09/2020 Foodhold U.S.A., LLC

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