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Name:Act Total Care Anticavity Fluoride Fresh Mint 2x
Manufacturer:Chattem, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ACT Total Care Anticavity Fluoride Rinse Fresh Mint 2X

ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT 2X - 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 Total Care Anticavity Fluoride Rinse Fresh Mint 2X

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

blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5 (283-007)

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

ALCOHOL FREE
fresh mint

STRONG TEETH + HEALTHY MOUTH + FRESH BREATH

ACT
®
TOTAL CARE
ANTICAVITY FLUORIDE

RINSE

STRENGTHENS Teeth

REBUILDS Enamel

HELPS PREVENT Cavities

KILL Bad Breath Germs

FRESHENS Breath

#1 DENTIST RECOMMENDED FLUORIDE BRAND

Sodium Fluoride 0.02%
use 2X a day

see directions

IMPORTANT: Read

directions for proper use

33.8 fl oz (1 L)

PRINCIPAL DISPLAY PANEL
ACT Total Care Anticavity Fluoride Rinse Fresh Mint 2X


ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT 2X 
sodium fluoride rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0962
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
FD&C BLUE NO. 1  
EDETATE CALCIUM DISODIUM ANHYDROUS  
CETYLPYRIDINIUM CHLORIDE  
METHYL SALICYLATE  
POLOXAMER 407  
POLYSORBATE 20  
POTASSIUM SORBATE  
PROPYLENE GLYCOL  
SODIUM BENZOATE  
SODIUM PHOSPHATE  
SACCHARIN SODIUM  
SORBITOL  
WATER  
FD&C YELLOW NO. 5  
Product Characteristics
Color GREEN Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0962-4 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 02/01/2009

Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Operations
VI-JON, INC. 790752542 MANUFACTURE

Revised: 03/2010 Chattem, Inc.



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


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