Firefly Anticavity Fluoride Rinse L.o.l. Surprise! Drug Facts

Firefly Anticavity Fluoride Rinse L.o.l. Surprise! Drug Facts
SPL v3
SPL
SPL Set ID 9f98913f-6754-4e1c-98cf-b89fe87750f8
Route
DENTAL
Published
Effective Date 2024-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (.5 mg)
Inactive Ingredients
Water Sorbitol Propylene Glycol Xylitol Sodium Benzoate Polyoxyl 40 Hydrogenated Castor Oil Sucralose Cetylpyridinium Chloride Poloxamer 407 Citric Acid Monohydrate Edetate Disodium Anhydrous Sodium Phosphate Sodium Phosphate, Dibasic, Anhydrous D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-16

Description

Sodium Fluoride 0.05%

Purpose

Anticavity rinse


Medication Information

Purpose

Anticavity rinse

Description

Sodium Fluoride 0.05%

Use

aids in the prevention of dental cavities.

Directions

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • 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.

Questions?

Toll Free: 1-866-373-7374

Active Ingredient

Sodium Fluoride 0.05%

Other Information
  • recommended storage temperature 59°-86°F(15°-30°C)
  • do not use if printed plastic neckband is broken or missing
Inactive Ingredients

purified water, sorbitol, propylene glycol, xylitol, sodium benzoate, PEG-40 hydrogenated castor oil, flavor, sucralose, cetylpyridinium chloride, poloxamer 407, citric acid, disodium EDTA, sodium phosphate, disodium phosphate, D&C red #33

Principal Display Panel

FIREFLY® ANTICAVITY Fluoride Rinse

L.O.L. SURPRISE!

WILD MELON

Helps PREVENT CAVITIES

ADA Accepted American Dental Association®

Helps prevent cavities

Alcohol FREE

IMPORTANT: Read directions for proper use.

16 FL OZ (473 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.

Purpose

Anticavity rinse

Directions

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • 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.

Questions?

Toll Free: 1-866-373-7374

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05%

Other Information
  • recommended storage temperature 59°-86°F(15°-30°C)
  • do not use if printed plastic neckband is broken or missing
Inactive Ingredients

purified water, sorbitol, propylene glycol, xylitol, sodium benzoate, PEG-40 hydrogenated castor oil, flavor, sucralose, cetylpyridinium chloride, poloxamer 407, citric acid, disodium EDTA, sodium phosphate, disodium phosphate, D&C red #33

Principal Display Panel

FIREFLY® ANTICAVITY Fluoride Rinse

L.O.L. SURPRISE!

WILD MELON

Helps PREVENT CAVITIES

ADA Accepted American Dental Association®

Helps prevent cavities

Alcohol FREE

IMPORTANT: Read directions for proper use.

16 FL OZ (473 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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