ACT ANTICAVITY FLUORIDE MINT- sodium fluoride rinse

ACT Anticavity Fluoride Mint by

Drug Labeling and Warnings

ACT Anticavity Fluoride Mint by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 (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

water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, green 3, yellow 5 (309-040)

Learn more at www. ACTFLUORIDE.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
Anticavity
Fluoride Mouthwash
alcohol free
MINT
33.8 fl oz (1 L)

INGREDIENTS AND APPEARANCE

ACT ANTICAVITY FLUORIDE MINT 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0962
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.09 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0962-4	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2009

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	Business Operations
VI-JON, INC.		790752542	MANUFACTURE(41167-0962)