Mouth Rinse Mouthwash
FDA Label NDC 30142-072

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 30142-072). 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 for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

Other Informatin

Cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59- 77F)

Inactive Ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin,  flavor, sodium citrate, D&C yellow no. 10, FD&C green no. 3

Questions Or Comments?

1-800-632-6900

Ada Council Statement

The ADA Council on Scientific Affairs' Acceptance of Kroger Mint  Burst Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

Disclaimer

Listerine is a registred trademark of Johnson & Johnson Healthcare Products, New Brunswick, NJ 08903.  Johnson & Johnson Healthcare Products is not affiliated with The Kroger Co. or this product.

Adverse Reactions

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OH 45202

QUALITY GUARANTEE

800-632-6900  www.kroger.com

072.002/072AL

Principal Display Panel

COMPARE to the active ingredients of LISTERINE * See back label

Kroger

FROM OUR FAMILY TO YOURS

Mint Burst

ANTISEPTIC

MOUTH RINSE

ANTGINGIVITIS/ANTIPLAQUE

  • Kills Germs That Cause Bad Breath, Plaque & the Gum Disease Gingivitis
  • For Fresher Breath
  • ADA

    Accepted

    American

    Dental

    Association

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    16.9 FL OZ (500 mL)

    Image Description (Mm1)

    Image Description (Mm1)

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