NDC Code(s) : 41167-0978-3, 41167-0978-6, 41167-0978-1
Packager : Chattem, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACT Restoring Anticavity Fluoride Mint BurstSodium fluoride MOUTHWASH
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0978
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SORBITOL(UNII: 506T60A25R)
POLOXAMER 407(UNII: TUF2IVW3M2)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM PHOSPHATE(UNII: SE337SVY37)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
CETYLPYRIDINIUM CHLORIDE(UNII: D9OM4SK49P)
EDETATE CALCIUM DISODIUM ANHYDROUS(UNII: 8U5D034955)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
Product Characteristics
Color green Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41167-0978-31000 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/12/2015
2NDC:41167-0978-61250 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/12/2015
3NDC:41167-0978-130 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product22/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M021 12/16/2015

LABELER - Chattem, Inc.(003336013)

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
BRAND FOR STRENGTHENING ENAMEL
ACT
RESTORING
ANTICAVITY FLUORIDE MOUTHWASH
MINT BURST
33.8 oz (1 L)

#1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L)