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Name:Act Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2x
Manufacturer:Chattem, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2X

ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X - 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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ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2X

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 is equal to 2 teaspoonfuls); do not use more than 10 milliliters
  • 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 (245-173)

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

use
2X

a day

see directions

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 0.02%

IMPORTANT: Read directions for proper use.

33.8 fl oz (1000
mL)

PRINCIPAL DISPLAY PANEL
ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2X


ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X 
sodium fluoride mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0980
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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
Color GREEN Score     
Shape Size
Flavor SPEARMINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0980-6 1000 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 02/01/2006

Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Operations
Chattem Plant 3 832973031 MANUFACTURE, PACK

Revised: 04/2011 Chattem, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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