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  5. Label Information: Act Total Care Dry Mouth Anticavity Mouth

FDA Label for Act Total Care Dry Mouth Anticavity 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. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRINCIPAL DISPLAY PANEL

Act Total Care Dry Mouth Anticavity 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


Other Information



  • do not use if safety seal is broken or missing

Inactive Ingredients



water, glycerin, sorbitol, xylitol, poloxamer 407, betaine, propylene glycol, flavors, bisabolol, carnosine, PEG-14M, PEG-160M, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (309-043)

Learn more at www.ACTFLUORIDE.com


Principal Display Panel



#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT® TOTAL CARE
ANTICAVITY FLUORIDE RINSE
DRY MOUTH
● SOOTHES Dry Mouth
● MOISTURIZES Mouth Tissue
● STRENGTHENS Teeth
● FRESHENS Breath
Sodium Fluoride 0.02%
18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL#1 DENTIST RECOMMENDED FLUORIDE BRANDACT® TOTAL CARE ANTICAVITY FLUORIDE RINSE DRY MOUTH● SOOTHES Dry Mouth● MOISTURIZES Mouth Tissue● STRENGTHENS Teeth● FRESHENS BreathSodium Fluoride 0.02%18 fl oz (532 mL) - act total care anticavity fluoride rinse dry mouth 01

PRINCIPAL DISPLAY PANEL#1 DENTIST RECOMMENDED FLUORIDE BRANDACT® TOTAL CARE ANTICAVITY FLUORIDE RINSE DRY MOUTH● SOOTHES Dry Mouth● MOISTURIZES Mouth Tissue● STRENGTHENS Teeth● FRESHENS BreathSodium Fluoride 0.02%18 fl oz (532 mL) - act total care anticavity fluoride rinse dry mouth 01


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