ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH SPEARMINT - sodium fluoride mouthwash
Chattem, Inc.

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ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint

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

do not use if safety seal is broken or missing

Inactive ingredients

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, green 3, yellow 10 (245-166)

www.actfluoride.com

ACT® RESTORINGTM

Anticavity Mouthwash

Restores essential
minerals to soft spots
Strengthens enamel to
help prevent tooth decay
Kills bad breath germs

CHATTEM®
Dist. by CHATTEM, INC.
P.O. Box 2219
Chattanooga, TN 37409 USA
© 2007 Chattem, Inc.

Patent Pending

*among fluoride mouth rinses

Bottle configuration
is a trademark of
Signal Investment &
Management Co.

PRINCIPAL DISPLAY PANEL

cool splashTM
spearmint
ACT®
RestoringTM
ANTICAVITY FLUORIDE
mouthwash
RESTORES
minerals to soft spots
STRENGTHENS
enamel to prevent
tooth decay
KILLS
bad breath germs
#1 DENTIST RECOMMENDED BRAND*
Sodium Fluoride 0.05%
IMPORTANT: Read
directions for proper use.
18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL
ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint

ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH SPEARMINT
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	41167-0956
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
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
PROPYLENE GLYCOL
SODIUM BENZOATE
SODIUM PHOSPHATE
POLYSORBATE 20
SACCHARIN SODIUM
CETYLPYRIDINIUM CHLORIDE
EDETATE CALCIUM DISODIUM ANHYDROUS
FD&C GREEN NO. 3
D&C YELLOW NO. 10

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

Packaging
#	NDC	Package Description	Multilevel Packaging
1	41167-0956-6	532 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	02/01/2006

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Operations
Access Business Group LLC		839830713	MANUFACTURE

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

Revised: 03/2010Chattem, Inc.