ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH SPEARMINT- 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, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, green 3, yellow 10 (245-166)

www.actfluoride.com

ACT® RESTORINGTM

Anticavity Mouthwash

  • Restores essential
    minerals to soft spots
  • Strengthens enamel to
    help prevent tooth decay
  • Kills bad breath germs

CHATTEM®
Dist. by CHATTEM, INC.
P.O. Box 2219
Chattanooga, TN 37409 USA
© 2007 Chattem, Inc.

Patent Pending

*among fluoride mouth rinses

Bottle configuration
is a trademark of
Signal Investment &
Management Co.

PRINCIPAL DISPLAY PANEL

cool splashTM
spearmint
ACT®
RestoringTM
ANTICAVITY FLUORIDE
mouthwash
RESTORES
minerals to soft spots
STRENGTHENS
enamel to prevent
tooth decay
KILLS
bad breath germs
#1 DENTIST RECOMMENDED BRAND*
Sodium Fluoride 0.05%
IMPORTANT: Read
directions for proper use.
18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint

ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH SPEARMINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0956
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 
POLYSORBATE 20 
SACCHARIN SODIUM 
CETYLPYRIDINIUM CHLORIDE 
EDETATE CALCIUM DISODIUM ANHYDROUS 
FD&C GREEN NO. 3 
D&C YELLOW NO. 10 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0956-6532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/2006
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 3832973031MANUFACTURE, PACK

Revised: 04/2011
Document Id: 650bb008-1340-40c3-8d47-9b9cb3d883dc
Set id: 7b61272b-346e-4597-9f5d-d4459f67554a
Version: 2
Effective Time: 20110416
 
Chattem, Inc.