Act Restoring Mint Burst 2x

Act Restoring Mint Burst 2x
SPL v8
SPL
SPL Set ID 0c7ede82-3b28-40ae-8dfd-cec58825f938
Route
ORAL
Published
Effective Date 2025-07-23
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 Sodium Phosphate Polysorbate 20 Saccharin Sodium Sucralose Sodium Phosphate, Dibasic, Anhydrous Cetylpyridinium Chloride Edetate Calcium Disodium Anhydrous Sodium Benzoate Potassium Sorbate Fd&c Yellow No. 5 Fd&c Green No. 3

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-12-16 Until 2018-07-07

Description

ACT ®   Restoring ™ Mint Burst Anticavity Fluoride Rinse Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

ACT ®   Restoring ™ Mint Burst Anticavity Fluoride Rinse Drug Facts

Use
  • aids in the prevention of dental cavities
Active

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

Section 42229-5

ACT ®   Restoring Mint Burst

Anticavity Fluoride Rinse

Drug Facts

Directions

a dults 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

c hildren under 6 years of age: consult a dentist or doctor

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, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-165)

Principal Display Panel

#1 DENTIST RECOMMENDED

BRAND FOR STRENGTHENING ENAMEL

ACT

RESTORING

ANTICAVITY FLUORIDE MOUTHWASH

MINT BURST

33.8 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
Active

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

Section 42229-5 (42229-5)

ACT ®   Restoring Mint Burst

Anticavity Fluoride Rinse

Drug Facts

Purpose

Anticavity

Directions

a dults 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

c hildren under 6 years of age: consult a dentist or doctor

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, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-165)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

#1 DENTIST RECOMMENDED

BRAND FOR STRENGTHENING ENAMEL

ACT

RESTORING

ANTICAVITY FLUORIDE MOUTHWASH

MINT BURST

33.8 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

All Sections (JSON)