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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0934
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
Color GREEN Score     
Shape Size
Flavor KIWI Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41167-0934-0 500 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 12/01/2012
Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Business Operations
Chattem Plant 3 832973031 ANALYSIS(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.