Tartar Control Plus Mouthwash
FDA Label NDC 41163-855

13 label sections · Submitted to the FDA by United Natural Foods, Inc. Dba Unfi · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Tartar Control Plus (NDC 41163-855). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 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, 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 Corporation, distributor of Listerine ®Ultraclean ®Cool Mint Antiseptic Mouthwash.

Adverse Reaction

Sealed With Printed Neckband For Your Protection

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI Providence, RI 02908 USA

DSP-TN-21091

DSP-MO-20087

Principal Display Panel

NDC 41163-855-86

compare to Listerine ®Ultraclean ®Cool Mint ®active ingredients*

EQUALINE ®

tartar control plus

antiseptic

mouthrinse

antigingivitis/antiplaque

  • kills germs that cause bad breath, plaque & the gum disease gingivitis
  • blue mint

    1 L (33.8 FL OZ)

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* Please review the disclaimer below.