ACT RESTORING ANTICAVITY FLUORIDE COOL MINT- sodium fluoride mouthwash

ACT Restoring Anticavity Fluoride Cool Mint by

Drug Labeling and Warnings

ACT Restoring Anticavity Fluoride Cool Mint 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

Drug Facts

Active ingredients

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, blue 1 (245-167)

www.actfluoride.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
1X Daily
RESTORING
ANTICAVITY FLUORIDE MOUTHWASH
COOL MINT
18 fl oz (532 mL)

INGREDIENTS AND APPEARANCE

ACT RESTORING ANTICAVITY FLUORIDE COOL MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0957
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 BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0957-5	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2006

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	Business Operations
Chattem Plant 3		832973031	LABEL(41167-0957) , MANUFACTURE(41167-0957) , PACK(41167-0957)