FIREFLY ANGRY BIRDS FLUORIDE- sodium fluoride aerosol, foam

Firefly Angry Birds Fluoride by

Drug Labeling and Warnings

Firefly Angry Birds Fluoride 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 0.243%

(0.15% w/v Fluoride ion)

Purpose

Anticavity

Uses

Helps protect against cavities

Warnings

Keep out of reach of children

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older, brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or a physician - Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) - Shake before use - Squirt once in your mouth or evenly on your toothbrush and brush - Supervise children as necessary until capable of using without supervision - Children under 2 years of age consult a dentist or physician

Inactive Ingredients

Aloe vera, citric acid, cocamidopropyl betaine, flavor, glycerin, menthol, poloxamer 407, purified water, silica, sodium benzoate, sodium hexametaphosphate, sucralose, tetrasodium pyrophosphate, xanthan gum, xylitol

Product Labeling

Firefly Squirt 'n' Brush Fluoride foam toothpaste

Angry Birds

Bubble gum flavor

MADE IN USA

Less Mess!

INGREDIENTS AND APPEARANCE

FIREFLY ANGRY BIRDS FLUORIDE 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-365
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64893-365-15	45 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/29/2012

Labeler - Dr. Fresh LLC (117376803)