FIREFLY MOUTH SWOOSH ANTI-CAVITY FLUORIDE RINSE- sodium fluoride liquid
Dr. Fresh, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse

Drug Facts

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose:

Anticavity Rinse

Uses

•: Aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age.

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 untill capable of using without supervision.
•: Children under 6 years of age: Consult a dentist or doctor.

Other information

Store at room temperature

Inactive ingredients

Cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, Bubble Gum Flavor, polysorbate 80, propylene glycol, FDandC Red No. 33, sodium benzoate, sodium phosphate monobasic, sodium saccharin, sorbitol, water, xylitol.

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FIREFLY MOUTH SWOOSH ANTI-CAVITY FLUORIDE RINSE
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-300
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-300-00	44 mL in 1 TUBE; Type 0: Not a Combination Product	09/02/2010	01/01/2015
2	NDC:64893-300-01	473 mL in 1 TUBE; Type 0: Not a Combination Product	09/02/2010	01/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/02/2010	01/01/2015

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: 53678308-48bc-4f51-b26d-0566d214ea4b

Set id: d6a63944-6efc-4c31-aa50-029bf5ca9811

Version: 7

Effective Time: 20210922

Dr. Fresh, LLC