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ACT Anticavity Fluoride Kids Bubblegum

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Chattem, Inc.
NDC Code: 41167-0944

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 Bubblegum

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, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water (245-163)

Learn more at www.actfluoride.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
alcohol free
NEW BOTTLE!
ACT Kids
Anticavity Fluoride Rinse
BubbleGum Blowout
16.9 fl oz (500 mL)

ACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0944
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE CALCIUM DISODIUM ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0944-130 mL in 1 BOTTLE, PLASTIC
2NDC:41167-0944-388 mL in 1 BOTTLE, PLASTIC
3NDC:41167-0944-23 BOTTLE, DISPENSING in 1 CELLO PACK
3NDC:41167-0944-8500 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/1993
Labeler - Chattem, Inc. (003336013)

Document Id: 016468f8-c790-4329-ad55-043ed38d7004
Set id: fbbccd58-a816-4a93-a658-f28246c11e80
Version: 7
Effective Time: 20150616
 
Chattem, Inc.

Medically reviewed on Jun 18, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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