ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT- sodium fluoride mouthwash 
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 0.05% (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 (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, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, cetylpyridinium chloride, polysorbate 20, sodium saccharin, disodium phosphate, calcium disodium EDTA, blue 1 (283-004)

www.actfluoride.com

† among fluoride mouth rinses

Bottle configuration is a registered trademark of
Signal Investment & Management Co. U.S. Patent D591, 159


CHATTEM ®
Dist. by CHATTEM, INC.
P.O. Box 2219
Chattanooga, TN 37409 USA
© 2010 Chattem, Inc.

PRINCIPAL DISPLAY PANEL

icy clean mint
STRONG TEETH + HEALTHY MOUTH + FRESH BREATH
ACT®
TOTAL CARE
ANTICAVITY FLUORIDE
MOUTHWASH
STRENGTHENS Teeth
REBUILDS Enamel
HELPS PREVENT Cavities
KILLS Bad Breath Germs
FRESHENS Breath
#1 DENTIST RECOMMENDED FLUORIDE BRAND†
Sodium Fluoride 0.05%
IMPORTANT: Read
directions for proper use
18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL ACT Total Care Anticavity Fluoride Mouthwash Icy Clean Mint

ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0965
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
CETYLPYRIDINIUM CHLORIDE 
POLYSORBATE 20 
SACCHARIN SODIUM 
EDETATE CALCIUM DISODIUM ANHYDROUS 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0965-0532 mL in 1 BOTTLE, PLASTIC
2NDC:41167-0965-388 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/2009
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
VI-JON, INC.790752542MANUFACTURE

Revised: 03/2010
Document Id: 2ed6dcfd-4851-4097-8878-5dd1040973fb
Set id: beded786-bb55-4ba3-82fe-9e9d1b5e2979
Version: 2
Effective Time: 20100329
 
Chattem, Inc.