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  5. Label Information: Original Antiseptic

FDA Label for Original Antiseptic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DENTIST
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. ADA COUNCIL STATEMENT
    12. SAFETY SEAL
    13. DISCLAIMER
    14. ADVERSE REACTION
    15. PRINCIPAL DISPLAY PANEL

Original Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Publix. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


* Please review the disclaimer below.