ACT ANTICAVITY FLUORIDE MINT- sodium fluoride rinse 
Chattem, Inc.

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.

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ACT Anticavity Fluoride Rinse Mint

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.009% 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 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

  • 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, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, green 3, yellow 5 (309-040)

Learn more at www. ACTFLUORIDE.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
Anticavity
Fluoride Mouthwash
alcohol free
MINT
33.8 fl oz (1 L)

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
Anticavity
Fluoride Mouthwash
alcohol free
MINT
33.8 fl oz (1 L)

ACT ANTICAVITY FLUORIDE MINT 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0962
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.09 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0962-41000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/200903/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/200903/31/2023
Labeler - Chattem, Inc. (003336013)

Revised: 3/2023
 
Chattem, Inc.