ACT BRACES CARE ANTICAVITY- sodium fluoride mouthwash 
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 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)

#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 DRUG LABELItem 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 
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 DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0952-3532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/01/2014
Labeler - Chattem, Inc. (003336013)

Revised: 4/2014
 
Chattem, Inc.