NDC Code(s) : 41167-0968-5, 41167-0968-0, 41167-0968-3, 41167-0968-9
Packager : Chattem, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACT Total Care Dry Mouth Anticavity MouthSodium Fluoride RINSE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0968
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.09 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)
POLYETHYLENE OXIDE 600000(UNII: 2126FD486L)
POLYETHYLENE OXIDE 7000000(UNII: G3MS6M810Y)
GINGER(UNII: C5529G5JPQ)
ANGELICA SINENSIS ROOT(UNII: B66F4574UG)
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)
PUERARIA MONTANA VAR. CHINENSIS ROOT(UNII: FQN0D1U235)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM PHOSPHATE(UNII: SE337SVY37)
DISODIUM PHOSPHATE(UNII: 22ADO53M6F)
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
1NDC:41167-0968-588 mL in 1 BOTTLE Type 0: Not a Combination Product02/01/2011
2NDC:41167-0968-0532 mL in 1 BOTTLE Type 0: Not a Combination Product02/01/2011
3NDC:41167-0968-31000 mL in 1 BOTTLE Type 0: Not a Combination Product02/01/2011
4NDC:41167-0968-930 mL in 1 BOTTLE Type 0: Not a Combination Product02/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M021 02/01/2011

LABELER - Chattem, Inc.(003336013)

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)

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)

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)