ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH- sodium fluoride rinse

ACT Total Care Dry Mouth Anticavity Mouth by

Drug Labeling and Warnings

ACT Total Care Dry Mouth Anticavity 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, flavors, bisabolol, carnosine, PEG-14M, PEG-160M, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (309-043)

Learn more at www.ACTFLUORIDE.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT® TOTAL CARE
ANTICAVITY FLUORIDE RINSE
DRY MOUTH
● SOOTHES Dry Mouth
● MOISTURIZES Mouth Tissue
● STRENGTHENS Teeth
● FRESHENS Breath
Sodium Fluoride 0.02%
18 fl oz (532 mL)

INGREDIENTS AND APPEARANCE

ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0968
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)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
PUERARIA MONTANA VAR. CHINENSIS ROOT (UNII: FQN0D1U235)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM PHOSPHATE (UNII: SE337SVY37)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LACTIC ACID (UNII: 33X04XA5AT)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
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: 41167-0968-0	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2011
2	NDC: 41167-0968-3	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2011
3	NDC: 41167-0968-5	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/01/2011

Labeler - Chattem, Inc. (003336013)