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ACT Braces Care Anticavity

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.09mg in 1mL
Labeler: Chattem, Inc.
NDC Code: 41167-0952

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 Braces Care Anticavity Fluoride Mouthwash

Active ingredient

Sodium fluoride 0.02% (0.009% 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 twice a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark
  • 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

water, sorbitol, xylitol, poloxamer 407, propylene glycol, aloe barbadensis leaf juice powder, tetrasodium pyrophosphate, sodium lauroyl sarcosinate, sodium laurate, glycerin, menthol, menthyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, benzyl alcohol, sodium benzoate, green 3, red 33 (309-092)

Learn more at ACTBRACESCARE.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND

NEW!

ACT BRACES CARE
Anitcavity Fluoride Mouthwash
Clean Mint

18 fl oz. (532
 mL)

ACT BRACES CARE ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0952
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.09 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
XYLITOL 
POLOXAMER 407 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
SODIUM PYROPHOSPHATE 
SODIUM LAUROYL SARCOSINATE 
SODIUM LAURATE 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
MENTHYL SALICYLATE, (+/-)- 
SODIUM PHOSPHATE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
POTASSIUM SORBATE 
POLYSORBATE 20 
SACCHARIN SODIUM 
CETYLPYRIDINIUM CHLORIDE 
EDETATE CALCIUM DISODIUM ANHYDROUS 
BENZYL ALCOHOL 
SODIUM BENZOATE 
FD&C GREEN NO. 3 
D&C RED NO. 33 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0952-3532 mL in 1 BOTTLE, PLASTIC
2NDC:41167-0952-530 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/03/2014
Labeler - Chattem, Inc. (003336013)

Revised: 05/2015
 
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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