Original Antiseptic Mouthwash
FDA Label NDC 56062-318

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc. for the product Original Antiseptic (NDC 56062-318). 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.

Label Section Quick Index

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

Use helps control plaque that leads to gingivitis

Warnings

Warnings

Do Not Use

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 dentist immediately. These may be signs of periodontitis , a serious form of gum disease.

Stop Use And Ask A Dentist

Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

Keep Out Of Reach Of Children

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

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

  • this rinse is not intended to replace brushing or flossing

Other Information

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

Inactive Ingredients

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

Ada Council Statement

The ADA Council on Scientific Affairs Acceptance of Publis Original Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduct gingivitis and plaque above the gumline, when used as directed

Safety Seal

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Disclaimer

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine

Adverse Reaction

Distributed by:

Publix Super Markets, Inc

3300 Publix Corporate Parkway

Lakeland FL 33811

publis.com

PUBLIX GUARANTEE:

COMPLETE SATISFACTION OR YOUR MONEY BACK

Principal Display Panel

Publix

Original

ANTISEPTIC MOUTH RINSE

Kills germs that cause:

  • bad breath
  • plaque
  • the gum disease Gingivitis

    • ADA

    Accepted

    American

    Dental

    Association

    COMPARE TO THE ACTIVE

    INGREDINTS OF LISTERINE

    1 l (33.8 FL OZ)

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