ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH SPEARMINT 2X- sodium fluoride mouthwash

ACT Restoring Anticavity Fluoride Cool Splash Spearmint 2X by

Drug Labeling and Warnings

ACT Restoring Anticavity Fluoride Cool Splash Spearmint 2X by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 3. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 into cap (10 mL is equal to 2 teaspoonfuls); do not use more than 10 milliliters
  
• 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 (245-173)

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

use
2X
a day
see directions
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 0.02%
IMPORTANT: Read directions for proper use.
33.8 fl oz (1000 mL)

INGREDIENTS AND APPEARANCE

ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH SPEARMINT 2X 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0980
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0980-6	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2006	05/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/01/2006	05/09/2020

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 3		832973031	MANUFACTURE(41167-0980) , PACK(41167-0980)