ACT WHITENING ANTICAVITY GENTLE MINT (sodium fluoride 0.02- 0.009 w/v fluoride ion mouthwash

ACT Whitening Anticavity Gentle Mint by

Drug Labeling and Warnings

ACT Whitening Anticavity Gentle 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 Whitening

Anticavity Gentle Mint 

Drug Facts

Active ingredient

Purpose

Sodium fluoride 0.02% (0.009% w/v fluoride ion)..........................................................................................Anticavity

Use

■ aids in the prevention of dental cavities  

Warnings

Stop use and ask a dentist if

oral irritation or tooth sensitivity occurs

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 12 years of age and older:

■ use twice a day after brushing your teeth with a toothpaste  

■ vigorously swish 10 milliliters (2 teaspoonfuls) 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

■ supervise children as necessary until capable of using without supervision

children under 12 years of age: consult a dentist or doctor

Other information

■ do not use if safety seal is broken or missing

Inactive ingredients

water, glycerin, xylitol, hydrogen peroxide, poloxamer 407, propylene glycol, pentylene glycol, flavors, sodium benzoate, sodium phosphate, disodium phosphate, 4-t-butylcyclohexanol, menthol, sucralose, sodium saccharin, calcium disodium EDTA

PRINCIPAL DISPLAY PANEL

ACT
WHITENING
ANTICAVITY FLUORIDE MOUTHWASH
GENTLE MINT
16.9 fl oz (500 mL)

 

INGREDIENTS AND APPEARANCE

ACT WHITENING ANTICAVITY GENTLE MINT 
sodium fluoride 0.02 (0.009 w/v fluoride ion) mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0983
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)
XYLITOL (UNII: VCQ006KQ1E)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
MENTHOL (UNII: L7T10EIP3A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0983-2	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	03/01/2019

Labeler - Chattem, Inc. (003336013)