ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH VANILLA MINT- sodium fluoride mouthwash
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 Restoring Anticavity Fluoride Mouthwash Cool Splash Vanilla 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

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 (245-168)

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
vanilla mint
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 Vanilla Mint

ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH VANILLA MINT
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0977
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0977-0	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2006	01/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	08/01/2006	01/30/2015

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
Access Business Group LLC		839830713	MANUFACTURE(41167-0977)

Revised: 5/2018

Document Id: 45a7a06d-bf61-489e-b8bb-0e276ba4121f

Set id: d4739432-c650-4a75-b08a-1ecff28e0151

Version: 3

Effective Time: 20180504

Chattem, Inc.