ACT Anticavity Kids iCarly Fluoride

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.5mg in 1mL
Labeler: Chattem, Inc.
NDC Code: 41167-0936

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 iCarly

Drug Facts

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 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 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, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, water (283-113)

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED FLUORIDE BRAND
NEW!
ACT® Anticavity KIDS
ALCOHOL FREE FLUORIDE RINSE
nickelodeon iCarlyTM
iBerry Blast
Sodium Fluoride 0.05%
IMPORTANT: Read directions for proper use
16.9 fl oz (500mL)

ACT ANTICAVITY KIDS ICARLY FLUORIDE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0936
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 
PHOSPHATE ION 
POLOXAMER 407 
POLYSORBATE 20 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SORBITOL 
SUCRALOSE 
WATER 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0936-1500 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/2011
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Chattem Plant 3832973031MANUFACTURE

Revised: 12/2010
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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