FIREFLY MOUTH SWOOSH ANTI-CAVITY FLUORIDE RINSE- sodium fluoride liquid

Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse by

Drug Labeling and Warnings

Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Dr. Fresh LLC (117376803)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Fresh LLC		117376803	manufacture(64893-300)