ACT ANTICAVITY FLUORIDE CINNAMON- 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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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

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5 (245-164)

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
cinnamon
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 Cinnamon

ACT ANTICAVITY FLUORIDE CINNAMON 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0940
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
BENZYL ALCOHOL 
EDETATE CALCIUM DISODIUM ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
FD&C YELLOW NO. 5 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0940-8532 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/01/1994
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 3832973031MANUFACTURE

Revised: 04/2011
Document Id: dedf1e38-f595-4d82-bf14-0aaab0c33d31
Set id: f2952ca5-c1c3-42fc-82a4-08662286be44
Version: 4
Effective Time: 20110416
 
Chattem, Inc.