Act Total Care Anticavity Fluoride Mouthwash Icy Clean Mint

Act Total Care Anticavity Fluoride Mouthwash Icy Clean Mint
SPL v9
SPL
SPL Set ID beded786-bb55-4ba3-82fe-9e9d1b5e2979
Route
TOPICAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Propylene Glycol Sodium Benzoate Sodium Phosphate Cetylpyridinium Chloride Polysorbate 20 Saccharin Sodium Edetate Calcium Disodium Anhydrous Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-02-01 Until 2018-01-08

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use
  • aids in the prevention of dental cavities
Section 42229-5

Drug Facts

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

Active Ingredient

Sodium fluoride 0.05% (0.02% 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, cetylpyridinium chloride, polysorbate 20, sodium saccharin, disodium phosphate, calcium disodium EDTA, blue 1 (283-004)

www.actfluoride.com

Principal Display Panel

#1 DENTIST RECOMMENDED

FLUORIDE BRAND

ACT ®

TOTAL CARE

ANTICAVITY FLUORIDE


MOUTHWASH

ICY CLEAN MINT

Sodium Fluoride 0.05%

18 fl oz (532 mL)

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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Anticavity

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

Active Ingredient (Active ingredient)

Sodium fluoride 0.05% (0.02% 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, cetylpyridinium chloride, polysorbate 20, sodium saccharin, disodium phosphate, calcium disodium EDTA, blue 1 (283-004)

www.actfluoride.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

#1 DENTIST RECOMMENDED

FLUORIDE BRAND

ACT ®

TOTAL CARE

ANTICAVITY FLUORIDE


MOUTHWASH

ICY CLEAN MINT

Sodium Fluoride 0.05%

18 fl oz (532 mL)

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


Raw Label Data

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