ACT ANTICAVITY FLUORIDE ICED SWEET MINT- sodium fluoride mouthwash

ACT Anticavity Fluoride Iced Sweet Mint by

Drug Labeling and Warnings

ACT Anticavity Fluoride Iced Sweet Mint by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACT

Anticavity Fluoride Mouthwash Iced Sweet Mint

Drug Facts

Active ingredient

Purpose

Sodium fluoride 0.05% (0.02% w/v fluoride ion)............................................................................................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 once a day after brushing your teeth with a toothpaste

■ remove cap

■ pour 10 milliliters into cap (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, sorbitol, xylitol, propylene glycol, poloxamer 407, tetrasodium pyrophosphate, sodium lauroyl sarcosinate, sodium laurate, PEG-35 castor oil, sucralose, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, dipotassium glycyrrhizate

PRINCIPAL DISPLAY PANEL

ACT
ICED
SWEET MINT
18 fl oz (532 mL)

INGREDIENTS AND APPEARANCE

ACT ANTICAVITY FLUORIDE ICED SWEET MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0946
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM LAURATE (UNII: K146MR5EXO)
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0946-2	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/02/2020

Labeler - Chattem, Inc. (003336013)