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  5. Label Information: Antispetic

FDA Label for Antispetic

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 IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS
    12. DISCLAIMER
    13. ADVERSE REACTIONS
    14. PRINCIPAL DISPLAY PANEL

Antispetic Product Label

The following document was submitted to the FDA by the labeler of this product Big Lots. 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



helps 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.

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 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3


Questions Or Comments



1-888-593-0593


Disclaimer



This product is not manufactured or distributed by Johnson & Johnson Healthcare products, distributor of Cool Mint Listerine Antiseptic Mouthwash


Adverse Reactions



Manufactured By; Vi-Jon, Inc.

for Big Lots

8515 Page Ave

St. Louis, MO 63114

V#425040

ITEM 664


Principal Display Panel



SOUND

BODY

COMPARE TO ACTIVE

INGREDENTS IN

LISTERINE

COOL MINT ANTISPETIC

Sealed With Printed Neckband For Your Protection

Antiseptic

Mouthrinse

ANTIGINGIVITIS/ANTIPLAQUE

Kills Germs That Cause:

* Please review the disclaimer below.