ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT - sodium fluoride rinse 
Chattem, Inc.

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ACT Total Care Anticavity Fluoride Rinse Fresh Mint

Drug Facts

Active ingredient

Sodium fluoride 0.05% (0.02% 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 once 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

• contains FD&C yellow no. 5 (tartrazine) as a color additive
  
• do not use if safety seal is broken or missing

Inactive ingredients

blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5 (283-006)

www.actfluoride.com

† among fluoride mouth rinses

Bottle configuration is a registered trademark of
Signal Investment & Management Co. U.S. Patent D591, 159

CHATTEM ®
Dist. by CHATTEM, INC.
P.O. Box 2219
Chattanooga, TN 37409 USA
© 2010 Chattem, Inc.

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE
fresh mint
STRONG TEETH + HEALTHY MOUTH + FRESH BREATH
ACT®
TOTAL CARE
ANTICAVITY FLUORIDE
RINSE
STRENGTHENS Teeth
REBUILDS Enamel
HELPS PREVENT Cavities
KILLS Bad Breath Germs
FRESHENS Breath
#1 DENTIST RECOMMENDED FLUORIDE BRAND †
Sodium Fluoride 0.05%
IMPORTANT: Read
directions for proper use
18 fl oz (532 mL)

ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT  sodium fluoride   rinse

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 41167-0961 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1   EDETATE CALCIUM DISODIUM ANHYDROUS   CETYLPYRIDINIUM CHLORIDE   MENTHOL   METHYL SALICYLATE   POLOXAMER 407   POLYSORBATE 20   POTASSIUM SORBATE   PROPYLENE GLYCOL   SODIUM BENZOATE   SODIUM PHOSPHATE   SACCHARIN SODIUM   SORBITOL   WATER   FD&C YELLOW NO. 5

Product Characteristics Color GREEN Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 41167-0961-0 532 mL In 1 BOTTLE, PLASTIC None 2 41167-0961-3 88 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/01/2009

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Operations
VI-JON, INC.		790752542	MANUFACTURE

Revised: 03/2010Chattem, Inc.