Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 30142-318

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 Antiseptic Mouth Rinse (NDC 30142-318). 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, 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 periodtitis, a serious form of gum disease.

Stop Use And Ask A Dentist

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 Information

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

Inactive Ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Questions Or Comments?

1-800-632-6900

Ada Council Statement

The ADA Council on Scientific Affairs Acceptance of Kroger Original Antisept Mouth Rinse is based opn its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used at directed.

Disclaimer

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

Adverse Reaction

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

800-632-6900   www.kroger.com

318.003/318AH

Principal Display Panel

COMPARE to the active ingredients of ORIGINAL LISTERINE

KROGER

FROM OUR FAMILY TO YOURS

Original

ANTISEPTIC

MOUTHRINSE

ANTIGINGIVITIS/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

    50.7FL OZ (1.5 L)

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