Mouth Rinse Mouthwash
FDA Label NDC 59450-901

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Mouth Rinse (NDC 59450-901). 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 {the rinse}

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°to 86°F)

Inactive Ingredients

water, alcohol (21.6% v/v), sorbitol, capryl/capramidopropyl betaine, flavor, benzoic acid, Stevia rebaudiana leaf extract, sodium benzoate

Questions Or Comments?

Call roll free 1-800-632-6900

Other

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

For More Proudct Information, Scan UpcUsing Your Kroger App or Call 800-632-6900

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SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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Breath & Gum Cleanser

ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

WITH ESSENTIAL OILS

HERBAL MINT

fights bad breath

helps prevent plaque & gingivitis

imrproves oral hygiene

for refreshing oral care

NO ARTIFICIAL SWEETNERS OR DYES

NO POLYETHYLENE GLYCOL

33.8 FL OZ (1.05 QT) 1L

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