1. Home
  2. Labeler Index
  3. Chattem, Inc.
  4. 41167-0944
  5. Label Information: Act Anticavity Fluoride Kids Bubblegum

FDA Label for Act Anticavity Fluoride Kids Bubblegum

View Indications, Usage & Precautions

Table of Contents

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

Act Anticavity Fluoride Kids Bubblegum Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, 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       0.05% (0.02% w/v fluoride ion)


Purpose



Anticavity


Use



  • aids in the prevention of dental cavities

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 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • remove cap
  • hold bottle upright and squeeze. Fill to FILL LINE
  • pour out. Only the correct 10 milliliters dose will pour out.
  • vigorously swish 10 milliliters 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
  • 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 years of age: consult a dentist or doctor


Other Information



  • do not use if safety seal is broken or missing

Inactive Ingredients



benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water (245-163)

Learn more at www.actfluoride.com


Principal Display Panel



#1 DENTIST RECOMMENDED
KID’s RINSE BRAND
ACT Kids
Anticavity 
Fluoride Rinse
Bubble Gum Blowout
16.9 fl oz (500 mL)

#1 DENTIST RECOMMENDEDKID’s RINSE BRANDACT KidsAnticavity Fluoride RinseBubble Gum Blowout16.9 fl oz (500 mL) - act anticavity fluoride rinse kids bubblegum 01

#1 DENTIST RECOMMENDEDKID’s RINSE BRANDACT KidsAnticavity Fluoride RinseBubble Gum Blowout16.9 fl oz (500 mL) - act anticavity fluoride rinse kids bubblegum 01


* Please review the disclaimer below.