ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH- sodium fluoride rinse

ACT Total Care Sensitive Anticavity Mint Mouth by

Drug Labeling and Warnings

ACT Total Care Sensitive Anticavity Mint Mouth 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

do not use

if safety seal is broken or missing

Inactive ingredients

water, glycerin, sorbitol, xylitol, poloxamer 407, betaine, propylene glycol, bisabolol, carnosine, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, PEG-14M, PEG-160M, flavors, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (283-180)

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT® 
TOTAL CARE
ANTICAVITY FLUORIDE MOUTHWASH
Sensitive FORMULA
Sodium Fluoride 0.02%
alcohol free
MINT
18 fl oz (532 mL)

INGREDIENTS AND APPEARANCE

ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0964
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)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BETAINE (UNII: 3SCV180C9W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LEVOMENOL (UNII: 24WE03BX2T)
CARNOSINE (UNII: 8HO6PVN24W)
GINGER (UNII: C5529G5JPQ)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
POLYETHYLENE GLYCOL 600000 (UNII: 2126FD486L)
POLYETHYLENE GLYCOL 7000000 (UNII: G3MS6M810Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM PHOSPHATE (UNII: SE337SVY37)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LACTIC ACID (UNII: 33X04XA5AT)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0964-1	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2012
2	NDC: 41167-0964-4	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/01/2012

Labeler - Chattem, Inc. (003336013)