FIREFLY ANTICAVITY FLUORIDE- sodium fluoride rinse

Firefly Anticavity Fluoride by

Drug Labeling and Warnings

Firefly Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Ranir LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride 0.05%

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities.

Warnings

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.

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

Questions?

Toll Free: 1-866-373-7374

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)

INGREDIENTS AND APPEARANCE

FIREFLY ANTICAVITY FLUORIDE 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66923-007
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66923-007-00	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/16/2021

Labeler - Ranir LLC (364567615)