ACT ANTICAVITY FLUORIDE FRESH 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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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 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

calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5 (283-167)

Learn more at www.ACTFLUORIDE.com
CHATTEM®
Dist. by CHATTEM, INC., P.O. Box 219, Chattanooga, TN 37409 USA
Bottle configuration is a registered trademark of Signal Investment & Management Co.
U.S. Patent No. D591,159 †among fluoride mouth rinses ©2011 Chattem, Inc.





PRINCIPAL DISPLAY PANEL

alcohol free mint ACT® Anticavity FLUORIDE rinse
use 2X a day see directions
HELPS PREVENT cavities
STRENGTHENS teeth
FRESHENS breath
#1 DENTIST RECOMMENDED FLUORIDE BRAND†
Sodium Fluoride 0.02%
IMPORTANT: Read directions for proper use.
33.8 fl oz (1L)

PRINCIPAL DISPLAY PANEL alcohol free mint ACT® Anticavity FLUORIDE rinse 33.8 fl oz (1L)

ACT ANTICAVITY FLUORIDE FRESH MINT 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0943
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE CALCIUM DISODIUM 
CETYLPYRIDINIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C GREEN NO. 3 
MENTHOL 
METHYL SALICYLATE 
POLOXAMER 407 
POLYSORBATE 20 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM ANHYDROUS 
SORBITOL 
WATER 
FD&C YELLOW NO. 5 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0943-31000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/2012
Labeler - Chattem, Inc. (003336013)

Revised: 03/2012
Document Id: 949939fd-22cb-4683-bfec-20e4100490d3
Set id: dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8
Version: 1
Effective Time: 20120308
 
Chattem, Inc.