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


ACT Anticavity Fluoride Rinse Fresh Mint

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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ACT Anticavity Fluoride Rinse Fresh Mint

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
  • hold bottle upright and squeeze. Fill to FILL LINE
  • pour out. Only the correct 10 milliliters dose will pour out.
  • 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 (245-165)

www.actfluoride.com

“The ADA Council on Scientific
Affairs’ Acceptance of ACT® is based on its finding that the product is effective in helping to prevent or reduce tooth decay, when used as directed.”

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

*among fluoride mouth rinses

Bottle configuration
is a trademark of
Signal Investment &
Management Co. 0073639-01

PRINCIPAL DISPLAY PANEL

alcohol free
mint

ACT
®
anticavity
FLUORIDE

rinse

HELPS PREVENT

cavities

STRENGTHENS

teeth

FRESHENS

breath

#1 DENTIST RECOMMENDED BRAND*

Sodium Fluoride 0.05%

IMPORTANT: Read

directions for proper use.

18 fl oz (532
mL)

PRINCIPAL DISPLAY PANEL
ACT Anticavity Fluoride Rinse Fresh Mint


ACT ANTICAVITY FLUORIDE FRESH MINT 
sodium fluoride rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0942
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE CALCIUM DISODIUM ANHYDROUS  
CETYLPYRIDINIUM CHLORIDE  
FD&C GREEN NO. 3  
MENTHOL  
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:41167-0942-8 532 mL in 1 BOTTLE, DISPENSING None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 04/01/1994

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

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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