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ACT Restoring Anticavity Fluoride Mint Burst

Medically reviewed on March 26, 2018

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.5mg in 1mL
Labeler: Chattem, Inc.
NDC Code: 41167-0979

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACT Restoring Mint Burst

ACT® RestoringMint Burst

Anticavity Fluoride Rinse

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use
  • aids in the prevention of dental cavities

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 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters into cap (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
  • contains FD&C yellow no. 5 (tartrazine) as a color additive
  • do not use if safety seal is broken or missing

Inactive ingredients

water, sorbitol, poloxamer 407, propylene glycol, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-166)

PRINCIPAL DISPLAY PANEL

ACT
Restoring Anticavity
Mouthwash
Mint Burst
18 fl oz (532 mL)

ACT RESTORING ANTICAVITY FLUORIDE MINT BURST 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0979
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
POLOXAMER 407 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE 
POLYSORBATE 20 
SACCHARIN SODIUM 
SUCRALOSE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
EDETATE CALCIUM DISODIUM ANHYDROUS 
SODIUM BENZOATE 
POTASSIUM SORBATE 
FD&C YELLOW NO. 5 
FD&C GREEN NO. 3 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0979-130 mL in 1 BOTTLE, PLASTIC
2NDC:41167-0979-388 mL in 1 BOTTLE, PLASTIC
3NDC:41167-0979-0532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/16/2015
Labeler - Chattem, Inc. (003336013)

 
Chattem, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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