Firefly Anticavity Fluoride Rinse Paw Patrol Drug Facts

Firefly Anticavity Fluoride Rinse Paw Patrol Drug Facts
SPL v2
SPL
SPL Set ID e91ed8a1-0d45-402c-9c16-1ae72e695a37
Route
DENTAL
Published
Effective Date 2021-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (.5 mg)
Inactive Ingredients
Cetylpyridinium Chloride Citric Acid Monohydrate Edetate Disodium Anhydrous Fd&c Blue No. 1 Menthol, Unspecified Form Poloxamer 407 Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sodium Phosphate Sorbitol Sucralose Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-16 Until 2023-08-23

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

cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, FD&C blue#1, flavor, menthol, poloxamer 407, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose, xylitol

Principal Display Panel

FIREFLY™ ANTICAVITY Fluoride Rinse

PAW PATROL™

BUBBLE GUM

nickelodeon

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

cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, FD&C blue#1, flavor, menthol, poloxamer 407, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose, xylitol

Principal Display Panel

FIREFLY™ ANTICAVITY Fluoride Rinse

PAW PATROL™

BUBBLE GUM

nickelodeon

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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