ACT WHITENING ANTICAVITY GENTLE MINT- sodium fluoride 0.02 (0.009 w/v fluoride ion) mouthwash 
Chattem, Inc.

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ACT Whitening Anticavity Fluoride Mouthwash Gentle Mint

ACT Whitening

Anticavity Gentle Mint 

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities  

Warnings

Stop use and ask a dentist if

oral irritation or tooth sensitivity occurs

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 12 years of age and older:

■ use twice a day after brushing your teeth with a toothpaste  

■ vigorously swish 10 milliliters (2 teaspoonfuls) 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

■ supervise children as necessary until capable of using without supervision

children under 12 years of age: consult a dentist or doctor

Other information

■ do not use if safety seal is broken or missing

Inactive ingredients

water, glycerin, xylitol, hydrogen peroxide, poloxamer 407, propylene glycol, pentylene glycol, flavors, sodium benzoate, sodium phosphate, disodium phosphate, 4-t-butylcyclohexanol, menthol, sucralose, sodium saccharin, calcium disodium EDTA

PRINCIPAL DISPLAY PANEL

ACT
WHITENING
ANTICAVITY FLUORIDE MOUTHWASH
GENTLE MINT
16.9 fl oz (500 mL)

PRINCIPAL DISPLAY PANEL
ACT
WHITENING
ANTICAVITY FLUORIDE MOUTHWASH
GENTLE MINT
16.9 fl oz (500 mL)
 PRINCIPAL DISPLAY PANEL
ACT
WHITENING
ANTICAVITY FLUORIDE MOUTHWASH
GENTLE MINT
16.9 fl oz (500 mL)

ACT WHITENING ANTICAVITY GENTLE MINT 
sodium fluoride 0.02 (0.009 w/v fluoride ion) mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0983
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.09 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
MENTHOL (UNII: L7T10EIP3A)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0983-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02103/01/2019
Labeler - Chattem, Inc. (003336013)

Revised: 10/2023
Document Id: a0c44cd8-2c6e-4599-a122-9e22022b3dd1
Set id: cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49
Version: 3
Effective Time: 20231020
 
Chattem, Inc.