Antispetic Mouthwash
FDA Label NDC 56062-072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc. for the product Antispetic (NDC 56062-072). 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.

Label Section Quick Index

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help control plaque that leads to gingivitis

Warnings

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 Information

cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

Inactive Ingredients

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

Ada Council Statement

The ADA Council on Scientific Affairs Acceptance of Publix Fresh Spearming Antiseptic Mouth Rinse is based on its finding tht the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

Disclaimer

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.

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

Adverse Reactions

Distributed by:

Publix Super Markets, Inc

3300 Publix Corporate Parkway

Lakeland, FL 33811

publix.com

PUBLIX GUARANTEE:

COMPLETE SATISFACTION OR YOUR MONEY BACK

Principal Display Panel

Publix

freshspearming

ANTISEPTIC MOUTH RINSE

kills gems that cause:

  • bad breath
  • plaque
  • the gum disease gingivitis

    • ADA

    Accepted

    American

    Dental

    Association

    COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE

    1 L (33.8 FL OZ)

    Image Description (Mm1)

    Image Description (Mm1)

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