ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH - sodium fluoride rinse 
Chattem, Inc.

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ACT Total Care Anticavity Fluoride Rinse Dry Mouth

Drug Facts

Active ingredient

Sodium flouoride 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 (283-122)

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE
Soothing MINT NEW!
ACT® TOTAL CARE ANTICAVITY FLUORIDE RINSE DRY MOUTH
● SOOTHES Dry Mouth
● MOISTURIZES Mouth Tissue
● STRENGTHENS Teeth
● FRESHENS Breath
#1 DENTIST RECOMMENDED FLUORIDE BRAND†
Sodium Fluoride 0.02%
Important: Read directions for proper use.
33.8 fl oz (1 L)

ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH  sodium fluoride   rinse

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 41167-0968 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.2 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength WATER   GLYCERIN   SORBITOL   XYLITOL   POLOXAMER 407   BETAINE   PROPYLENE GLYCOL   LEVOMENOL   CARNOSINE   GINGER   LONICERA JAPONICA FLOWER   PUERARIA MONTANA VAR. CHINENSIS ROOT   SODIUM BENZOATE   POTASSIUM SORBATE   SODIUM PHOSPHATE   POLYSORBATE 20   LACTIC ACID   EDETATE CALCIUM DISODIUM ANHYDROUS   CETYLPYRIDINIUM CHLORIDE   SUCRALOSE   FD&C GREEN NO. 3   D&C YELLOW NO. 10

Product Characteristics Color      Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 41167-0968-0 532 mL In 1 BOTTLE None 2 41167-0968-3 1000 mL In 1 BOTTLE None 3 41167-0968-5 88 mL In 1 BOTTLE None

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)

Establishment
Name	Address	ID/FEI	Operations
Chattem Plant 3		832973031	MANUFACTURE, PACK

Revised: 03/2011Chattem, Inc.