ACT ANTICAVITY FLUORIDE KIDS SPONGEBOB- 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 Ingredients

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 line 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

  • do not use if safety seal is broken or missing

Inactive ingredients

benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water

www.actfluoride.com

*among fluoride mouth rinses

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

© 2009 Viacom International Inc.
All Rights Reserved. NickelodeonTM,
SpongeBob SquarePantsTM and all related
titles, logos and characters are trademarks
of Viacom International Inc. SpongeBob
SquarePantsTM created by
Stephen Hillenburg. www.NICK.com

CHATTEM®

Dist. by CHATTEM, INC.
P.O. Box 2219, Chattanooga, TN 37409 USA
© 2009 Chattem, Inc. 0077697-01

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED BRAND*
NEW!
ACT®
Anticavity 
KiDS
ALCOHOL FREE FLUORIDE RINSE
OCEAN BERRY
nickelodeonTM
SpongeBOB
SQUAREPANTSTM
Sodium Fluoride 0.05%
IMPORTANT: Read
directions for proper use
16.9 fl oz (500 mL)

PRINCIPAL DISPLAY PANEL - ACT Anticavity Fluoride Rinse Kids Spongebob

ACT ANTICAVITY FLUORIDE KIDS SPONGEBOB 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0935
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 
FD&C BLUE NO. 1 
EDETATE CALCIUM DISODIUM ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
POLOXAMER 407 
POLYSORBATE 20 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SORBITOL 
SUCRALOSE 
WATER 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0935-0500 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/2010
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 3832973031MANUFACTURE

Revised: 04/2011
Document Id: 91bb9210-fe3c-4213-afd1-08d4a4c5b001
Set id: 56efc245-9839-4a11-b89b-5f57539fd0f3
Version: 4
Effective Time: 20110416
 
Chattem, Inc.