Act Restoring Anticavity Fluoride Mouthwash Cool Mint

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.09 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2006-02-01 Until 2018-08-26

Medication Information

Purpose

Anticavity

Description

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

Use

aids in the prevention of dental cavities

Directions

adults and children 6 years of age and older:

use twice 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

Active Ingredient

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

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 (245-172)

www.actfluoride.com

Principal Display Panel

#1 DENTIST RECOMMENDED

BRAND FOR STRENTHENING ENAMEL

ACT

RESTORING

ANTICAVITY FLUORIDE MOUTHWASH

COOL MINT

33.8 fl oz. (1 L)

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.

Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Directions

adults and children 6 years of age and older:

use twice 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

Active Ingredient

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

Other Information (Other information)

do not use if safety seal is broken or missing

Inactive Ingredients (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 (245-172)

www.actfluoride.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

#1 DENTIST RECOMMENDED

BRAND FOR STRENTHENING ENAMEL

ACT

RESTORING

ANTICAVITY FLUORIDE MOUTHWASH

COOL MINT

33.8 fl oz. (1 L)

Keep Out of Reach of Children. (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.

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.09", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE", "unii": "SE337SVY37", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE CALCIUM DISODIUM ANHYDROUS", "unii": "8U5D034955", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity", "Directions": "adults and children 6 years of age and older: use twice 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", "Active Ingredient": "Sodium fluoride 0.02% (0.009% w/v fluoride ion)", "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 (245-172) www.actfluoride.com", "PRINCIPAL DISPLAY PANEL": "#1 DENTIST RECOMMENDED BRAND FOR STRENTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL MINT 33.8 fl oz. (1 L)", "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."}

Act Restoring Anticavity Fluoride Mouthwash Cool Mint

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information