Act Anticavity Fluoride Rinse Mint

Act Anticavity Fluoride Rinse Mint
SPL v15
SPL
SPL Set ID e81c83a2-363a-442f-8731-2598a4f4c21e
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 Sorbitol Poloxamer 407 Propylene Glycol Menthol Methyl Salicylate Sodium Phosphate Sodium Phosphate, Dibasic, Anhydrous Potassium Sorbate Polysorbate 20 Saccharin Sodium Mint Cetylpyridinium Chloride Edetate Calcium Disodium Anhydrous Sodium Benzoate Fd&c Green No. 3 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 1994-04-01 Until 2011-03-15

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

  • hold bottle upright and squeeze. Fill to FILL LINE (10 mL)

  • 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
  • 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, green 3, yellow 5



Learn more at www.ACTFLUORIDE.com

Principal Display Panel

ZERO ALCOHOL

#1 DENTIST RECOMMENDED

FLUORIDE BRAND


ACT


1X Daily


ANTICAVITY


FLUORIDE MOUTHWASH


MINT


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

  • hold bottle upright and squeeze. Fill to FILL LINE (10 mL)

  • 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)
  • 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, green 3, yellow 5



Learn more at www.ACTFLUORIDE.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ZERO ALCOHOL

#1 DENTIST RECOMMENDED

FLUORIDE BRAND


ACT


1X Daily


ANTICAVITY


FLUORIDE MOUTHWASH


MINT


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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