Your browser does not support JavaScript! ACT ANTICAVITY FLUORIDE RINSE KIDS SCOOBY DOO (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]
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ACT ANTICAVITY FLUORIDE RINSE KIDS SCOOBY DOO (sodium fluoride) rinse
[Chattem, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 accidently swallowed, get medical help or contact 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

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
 
Chattem, Inc.

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