Act Total Care Anticavity Fluoride Rinse Fresh Mint

Act Total Care Anticavity Fluoride Rinse Fresh Mint
SPL v11
SPL
SPL Set ID dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8
Route
TOPICAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.09 mg)
Inactive Ingredients
Edetate Calcium Disodium Cetylpyridinium Chloride Sodium Phosphate, Dibasic, Dihydrate Fd&c Green No. 3 Menthol Methyl Salicylate Poloxamer 407 Polysorbate 20 Potassium Sorbate Propylene Glycol Sodium Benzoate Sodium Phosphate Saccharin Sodium Anhydrous Sorbitol Water Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-01

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 twice 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

Active Ingredient

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

Other Information
  • contains FD&C yellow no. 5 (tartrazine) as a color additive

  • do not use if safety seal is broken or missing
Inactive Ingredients

water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, blue 1, yellow 5

Learn more at www. ACTFLUORIDE.com

Principal Display Panel

#1 DENTIST RECOMMENDED

FLUORIDE BRAND

ACT

Anticavity

Fluoride Mouthwash

alcohol free

FRESH 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
Section 42229-5 (42229-5)

Drug Facts

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

Other Information (Other information)
  • contains FD&C yellow no. 5 (tartrazine) as a color additive

  • do not use if safety seal is broken or missing
Inactive Ingredients (Inactive ingredients)

water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, blue 1, yellow 5

Learn more at www. ACTFLUORIDE.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

#1 DENTIST RECOMMENDED

FLUORIDE BRAND

ACT

Anticavity

Fluoride Mouthwash

alcohol free

FRESH 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


Raw Label Data

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