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  5. Label Information: Anticavity Fluoride Rinse

FDA Label for Anticavity Fluoride Rinse

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. OTHER
    10. PRINCIPAL DISPLAY PANEL

Anticavity Fluoride Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Publix Super Markets, Inc. 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 Ingredient



Sodium fluoride 0.0221% (0.01% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities


Warnings



Warnings


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:

  • use twice daily after brushing your teeth with toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor

Other Information



  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive Ingredients



water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1


Other



*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash.

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811 publix.com


Principal Display Panel



Publix

EUCALYPTUS MINT

anticavity

FLUORIDE MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

  • Helps prevent cavities
  • Restores enamel
  • Helps strengthen teeth
  • Helps kill germs that cause bad breath

    • Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash*

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    IMPORTANT: READ DIRECTIONS FOR PROPER USE.

    1 L (33.8 FL OZ)

    163.004/163AE

    image description - mm1

    image description - mm1


* Please review the disclaimer below.