ACT ANTICAVITY FLUORIDE ICED BERRY- 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 Anticavity Fluoride Mouthwash Iced Berry

ACT

Anticavity Fluoride Mouthwash Iced Berry

Drug Facts

Active ingredient

Purpose

Sodium fluoride 0.05% (0.02% w/v fluoride ion)............................................................................................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

■ pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above 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, propylene glycol, poloxamer 407, tetrasodium pyrophosphate, sodium lauroyl sarcosinate, sodium laurate, PEG-35 castor oil, sucralose, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, dipotassium glycyrrhizate

PRINCIPAL DISPLAY PANEL

ACT
1 X Daily
ANTICAVITY
Fluoride Mouthwash
Iced Berry
18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL
ACT
1 X Daily
ANTICAVITY
Fluoride Mouthwash
Iced Berry
18 fl oz (532 mL)
 PRINCIPAL DISPLAY PANEL
ACT
1 X Daily
ANTICAVITY
Fluoride Mouthwash
Iced Berry
18 fl oz (532 mL)

ACT ANTICAVITY FLUORIDE ICED BERRY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0947
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
SODIUM LAURATE (UNII: K146MR5EXO)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0947-1532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/202010/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/02/202010/31/2022
Labeler - Chattem, Inc. (003336013)

Revised: 1/2023
 
Chattem, Inc.