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  5. Label Information: Anticavity

FDA Label for Anticavity

View Indications, Usage & Precautions

Table of Contents

    1. TEP
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENT
    10. ADA COUNCIL STATEMENT
    11. DISCLAIMER
    12. ADVERSE REACTION
    13. PRINCIPAL DISPLAY PANEL

Anticavity Product Label

The following document was submitted to the FDA by the labeler of this product United Natural Foods, Inc. Dba Unfi. 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.

Tep



Sealed with printed neckband for your protection


Active Ingredient



Sodium fluoride 0.05% (0.02% w/v fluoride ion)


Purpose



Anticavity rinse


Use



aids in the prevention of dental cavities


Warnings



For this product


Keep Out Of Reach Of Children



If more than used for rinsing is accidentally swallowed, see professional assistance or contact a Poison Control Center immediately.


Directions



  • adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 millilitrs of rinse between your teeth for 1 minute then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 miutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 year of age: consult a dentist or doctor

Other Information



  • store at room temperture

Inactive Ingredient



benzyl alcohol, calcium disodium EDTA, cetylpyridiniun chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water


Ada Council Statement



The ADA Council on Scientifc Affairs Acceptance of Equaline Kids Anticavity Fluoride Rine is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.


Disclaimer



This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse.


Adverse Reaction



DISTRIBUTED BY SUPERVALU INC.

EDEN PAIRIE, MN 55344 USA

Contacty us at 1-877-932-7948,

or www.supervalu-ourownbrands.com


Principal Display Panel



Compare to Act Bubblegum

Blowout Anticavity Fluoride Rinse

active ingredent

EQUALINE

kids

anticavity

fluoride

rinse

ADA

Accepted

American

Dental

Association

  • strong cavity protection
  • helps strengthen teeth
  • alcohol free

    • bubblegum flavor

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    18 FL OZ (532 mL)


* Please review the disclaimer below.