ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT- sodium fluoride rinse

ACT Total Care Anticavity Fluoride Fresh Mint by

Drug Labeling and Warnings

ACT Total Care Anticavity Fluoride Fresh 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 0.05% (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

• contains FD&C yellow no. 5 (tartrazine) as a color additive
  
• do not use if safety seal is broken or missing

Inactive ingredients

blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5 (283-006)

www.actfluoride.com

† among fluoride mouth rinses

Bottle configuration is a registered trademark of
Signal Investment & Management Co. U.S. Patent D591, 159

CHATTEM ®
Dist. by CHATTEM, INC.
P.O. Box 2219
Chattanooga, TN 37409 USA
© 2010 Chattem, Inc.

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE
fresh mint
STRONG TEETH + HEALTHY MOUTH + FRESH BREATH
ACT®
TOTAL CARE
ANTICAVITY FLUORIDE
RINSE
STRENGTHENS Teeth
REBUILDS Enamel
HELPS PREVENT Cavities
KILLS Bad Breath Germs
FRESHENS Breath
#1 DENTIST RECOMMENDED FLUORIDE BRAND †
Sodium Fluoride 0.05%
IMPORTANT: Read
directions for proper use
18 fl oz (532 mL)

INGREDIENTS AND APPEARANCE

ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0961
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)

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: 41167-0961-0	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2009
2	NDC: 41167-0961-3	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2009	02/17/2018
3	NDC: 41167-0961-4	1900 mL in 1 BOTTLE; 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)