arc after whitening rinse

arc after whitening rinse
SPL v7
SPL
SPL Set ID dad50805-dd1a-fc0b-e053-2995a90a1bb8
Route
oral
Published
Effective Date 2021-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 mg)
Inactive Ingredients
water benzoic acid phosphoric acid sodium benzoate polysorbate 80 poloxamer 407 sucralose sodium phosphate, dibasic, anhydrous propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-06-01

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
  • Adults and children 6 years & older:
    • Use twice a day after brushing your teeth with a toothpaste.
    • Vigorously swish 10 mL 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.
Inactive Ingredients

water, propylene glycol, poloxamer 407, polysorbate 80, benzoic acid, flavor, sucralose, sodium benzoate, phosphoric acid, disodium phosphate

Description

Drug Facts

Questions?

1-866-989-3951

Use

Aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

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.

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Principal Display Panel 475 Ml Bottle Label

ENAMEL

STRENGTHENING

ARC

AFTER WHITENING

ANTICAVITY FLUORIDE RINSE

475 mL (16 FL OZ)

IMPORTANT: Read directions for proper use.


Structured Label Content

Purpose

Anticavity

Directions
  • Adults and children 6 years & older:
    • Use twice a day after brushing your teeth with a toothpaste.
    • Vigorously swish 10 mL 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.
Inactive Ingredients (Inactive ingredients)

water, propylene glycol, poloxamer 407, polysorbate 80, benzoic acid, flavor, sucralose, sodium benzoate, phosphoric acid, disodium phosphate

Questions?

1-866-989-3951

Use

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Principal Display Panel 475 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label)

ENAMEL

STRENGTHENING

ARC

AFTER WHITENING

ANTICAVITY FLUORIDE RINSE

475 mL (16 FL OZ)

IMPORTANT: Read directions for proper use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)