ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH- sodium fluoride rinse 
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 Total Care Anticavity Fluoride Rinse Dry Mouth

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

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 (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, glycerin, sorbitol, xylitol, poloxamer 407, betaine, propylene glycol, flavors, bisabolol, carnosine, PEG-14M, PEG-160M, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (309-043)

Learn more at www.ACTFLUORIDE.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT® TOTAL CARE
ANTICAVITY FLUORIDE RINSE
DRY MOUTH
● SOOTHES Dry Mouth
● MOISTURIZES Mouth Tissue
● STRENGTHENS Teeth
● FRESHENS Breath
Sodium Fluoride 0.02%
18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT® TOTAL CARE ANTICAVITY FLUORIDE RINSE DRY MOUTH ● SOOTHES Dry Mouth ● MOISTURIZES Mouth Tissue ● STRENGTHENS Teeth ● FRESHENS Breath Sodium Fluoride 0.02% 18 fl oz (532 mL) PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT® TOTAL CARE ANTICAVITY FLUORIDE RINSE DRY MOUTH ● SOOTHES Dry Mouth ● MOISTURIZES Mouth Tissue ● STRENGTHENS Teeth ● FRESHENS Breath Sodium Fluoride 0.02% 18 fl oz (532 mL)

ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0968
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)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BETAINE (UNII: 3SCV180C9W)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LEVOMENOL (UNII: 24WE03BX2T)  
CARNOSINE (UNII: 8HO6PVN24W)  
GINGER (UNII: C5529G5JPQ)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
PUERARIA MONTANA VAR. CHINENSIS ROOT (UNII: FQN0D1U235)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
LACTIC ACID (UNII: 33X04XA5AT)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0968-588 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
2NDC:41167-0968-0532 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
3NDC:41167-0968-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
4NDC:41167-0968-930 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2011
Labeler - Chattem, Inc. (003336013)

Revised: 2/2022
Document Id: 25c301d0-98c6-4398-8572-8ef120eb1791
Set id: 06684b82-aaa0-4ca6-8d56-4f9866269000
Version: 9
Effective Time: 20220223
 
Chattem, Inc.