ACT ANTICAVITY FLUORIDE RINSE KIDS SCOOBY DOO- 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.

----------

ACT Anticavity Fluoride Rinse Kids Scooby Doo

Active ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity  

Use

Warnings

Keep out of reach of children.

If more than used for rinsing is accidently swallowed, get medical help or contact Poison Control Center right away.

Directions

adults and children 6 years of age and older:

children under 6 years of age: consult a dentist or doctor.

Other Information

Inactive ingredients

calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)

Principal Display Panel

ACT Kids
Anticavity Fluoride Rinse
Scooby-Doo! Kiwi Watermelon
Sodium Fluoride 0.05%
16.9 fl oz (500 mL)

ACT  Kids
Anticavity Fluoride Rinse
 Scooby-Doo! Kiwi Watermelon
Sodium Fluoride 0.05%
16.9 fl oz (500 mL)

ACT ANTICAVITY FLUORIDE RINSE KIDS SCOOBY DOO 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-0934
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE CALCIUM DISODIUM ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C GREEN NO. 3 
POLOXAMER 407 
POLYSORBATE 20 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SORBITOL 
SUCRALOSE 
WATER 
FD&C YELLOW NO. 5 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorKIWIImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0934-0500 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2012
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 3832973031ANALYSIS(41167-0934), LABEL(41167-0934), MANUFACTURE(41167-0934), PACK(41167-0934), RECOVERY(41167-0934), RELABEL(41167-0934), REPACK(41167-0934)

Revised: 3/2013
Document Id: aa9673b7-f427-48e9-8beb-193ea0f7098e
Set id: 133d37bc-4b0c-4186-9afc-5dd78ba773b1
Version: 1
Effective Time: 20130326
 
Chattem, Inc.