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  5. Label Information: Act Total Care Sensitive Anticavity Mint Mouth

FDA Label for Act Total Care Sensitive Anticavity Mint Mouth

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. KEEP OUT OF REACH OF CHILDREN.
    5. DIRECTIONS
    6. DO NOT USE
    7. INACTIVE INGREDIENTS
    8. PRINCIPAL DISPLAY PANEL

Act Total Care Sensitive Anticavity Mint Mouth 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 0.02% (0.009% 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 twice a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • 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


Do Not Use



if safety seal is broken or missing


Inactive Ingredients



water, glycerin, sorbitol, xylitol, poloxamer 407, betaine, propylene glycol, bisabolol, carnosine, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, PEG-14M, PEG-160M, flavors, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (283-180)


Principal Display Panel



#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT® 
TOTAL CARE
ANTICAVITY FLUORIDE MOUTHWASH
Sensitive FORMULA
Sodium Fluoride 0.02%
alcohol free
MINT
18 fl oz (532 mL)

#1 DENTIST RECOMMENDEDFLUORIDE BRANDACT® TOTAL CAREANTICAVITY FLUORIDE MOUTHWASHSensitive FORMULASodium Fluoride 0.02%alcohol freeMINT18 fl oz (532 mL) - act total care sensitive anticavity mouth rinse se 01

#1 DENTIST RECOMMENDEDFLUORIDE BRANDACT® TOTAL CAREANTICAVITY FLUORIDE MOUTHWASHSensitive FORMULASodium Fluoride 0.02%alcohol freeMINT18 fl oz (532 mL) - act total care sensitive anticavity mouth rinse se 01


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