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

Purpose

Anticavity rinse

Description

Sodium Fluoride 0.05%


Medication Information

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.

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

Description

Sodium Fluoride 0.05%

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)

Questions?

Toll Free: 1-866-373-7374

Use

aids in the prevention of dental cavities.

Active Ingredient

Sodium Fluoride 0.05%

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

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.

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)

Questions?

Toll Free: 1-866-373-7374

Use

aids in the prevention of dental cavities.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05%

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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