ACT Restoring Anticavity Fluoride Cool Mint

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Chattem, Inc.
NDC code: 41167-0957

Medically reviewed by Drugs.com. Last updated on Jan 22, 2024.

ACT Restoring Anticavity Fluoride Mouthwash Cool Mint

Drug Facts

Active ingredients

Sodium fluoride 0.05% (0.02% 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 once 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, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1 (245-167)

www.actfluoride.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
1X Daily
RESTORING
ANTICAVITY FLUORIDE MOUTHWASH
COOL MINT
18 fl oz (532 mL)

ACT RESTORING ANTICAVITY FLUORIDE COOL MINT
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0957
Route of Administration	TOPICAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
PROPYLENE GLYCOL
SODIUM BENZOATE
SODIUM PHOSPHATE
POLYSORBATE 20
SACCHARIN SODIUM
CETYLPYRIDINIUM CHLORIDE
EDETATE CALCIUM DISODIUM ANHYDROUS
FD&C BLUE NO. 1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:41167-0957-5	532 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/01/2006

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Operations
CHATTEM, INC.		832973031	LABEL(41167-0957), MANUFACTURE(41167-0957), PACK(41167-0957)

Document Id: 4b09f653-56ec-4faa-858d-6044fcad286f

Set id: ef63e193-5804-4b35-bae7-cad29cf4e8bc

Version: 8

Effective Time: 20060201

Chattem, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer