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


ACT Anticavity Fluoride Rinse Kids Spongebob

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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ACT Anticavity Fluoride Rinse Kids Spongebob

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
SQUAREPANTS
TM
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 Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0935
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
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
Color BLUE Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0935-0 500 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 02/01/2010

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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