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Name:Act Total Care Dry Mouth Anticavity Mouth
Manufacturer:Chattem, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ACT Total Care Anticavity Fluoride Rinse Dry Mouth

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 flouoride 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 (283-122)

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE
Soothing MINT NEW!

ACT
® TOTAL CARE ANTICAVITY FLUORIDE RINSE DRY MOUTH
 SOOTHES Dry Mouth
 MOISTURIZES Mouth Tissue
 STRENGTHENS Teeth
 FRESHENS Breath
#1 DENTIST RECOMMENDED FLUORIDE BRAND
Sodium Fluoride 0.02%
Important: Read directions for proper use.
33.8 fl oz (1 L)

PRINCIPAL DISPLAY PANEL
ACT Total Care Anticavity Fluoride Rinse Dry Mouth
33.8 fl oz (1 L)


ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH 
sodium fluoride rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0968
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
SORBITOL  
XYLITOL  
POLOXAMER 407  
BETAINE  
PROPYLENE GLYCOL  
LEVOMENOL  
CARNOSINE  
GINGER  
LONICERA JAPONICA FLOWER  
PUERARIA MONTANA VAR. CHINENSIS ROOT  
SODIUM BENZOATE  
POTASSIUM SORBATE  
SODIUM PHOSPHATE  
POLYSORBATE 20  
LACTIC ACID  
EDETATE CALCIUM DISODIUM ANHYDROUS  
CETYLPYRIDINIUM CHLORIDE  
SUCRALOSE  
FD&C GREEN NO. 3  
D&C YELLOW NO. 10  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0968-0 532 mL in 1 BOTTLE None
2 NDC:41167-0968-3 1000 mL in 1 BOTTLE None
3 NDC:41167-0968-5 88 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 02/01/2011

Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Operations
Chattem Plant 3 832973031 MANUFACTURE, PACK

Revised: 03/2011 Chattem, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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