ACT TOTAL CARE SENSITIVE ANTICAVITY MILD MINT 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.

----------

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, bisabolol, carnosine, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, PEG-14M, PEG-160M, flavors, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (283-180)

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE
mild MINT
ACT® TOTAL CARE ANTICAVITY FLUORIDE MOUTHWASH
Sensitive FORMULA*
#1 DENTIST RECOMMENDED FLUORIDE BRAND†
Sodium Fluoride 0.02%
IMPORTANT: Read directions for proper use.
*DOES NOT RELIEVE OR TREAT SENSITIVE TEETH, ORAL PAIN OR GUM DISEASE.
18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL ALCOHOL FREE mild MINT ACT® TOTAL CARE ANTICAVITY FLUORIDE MOUTHWASH Sensitive FORMULA* Sodium Fluoride 0.02% 18 fl oz (532 mL)

ACT TOTAL CARE SENSITIVE ANTICAVITY MILD MINT MOUTH 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0964
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.02 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
SORBITOL 
XYLITOL 
POLOXAMER 407 
BETAINE 
PROPYLENE GLYCOL 
LEVOMENOL 
CARNOSINE 
GINGER 
ANGELICA SINENSIS ROOT 
LONICERA JAPONICA FLOWER 
PUERARIA MONTANA VAR. LOBATA ROOT 
POLYETHYLENE GLYCOL 600000 
POLYETHYLENE GLYCOL 7000000 
SODIUM BENZOATE 
POTASSIUM SORBATE 
SODIUM PHOSPHATE 
POLYSORBATE 20 
LACTIC ACID 
EDETATE CALCIUM DISODIUM 
CETYLPYRIDINIUM CHLORIDE 
SUCRALOSE 
FD&C GREEN NO. 3 
D&C YELLOW NO. 10 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0964-1532 mL in 1 BOTTLE
2NDC:41167-0964-41000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/2012
Labeler - Chattem, Inc. (003336013)

Revised: 02/2012
Document Id: f7d15074-437f-4a62-b415-dc8417ef0bc4
Set id: d2e7d60a-f293-4932-8e55-76b6edb6fc10
Version: 1
Effective Time: 20120210
 
Chattem, Inc.