FIREFLY BARBIE FLUORIDE FOAM BUBBLEGUM FLAVOR- sodium fluoride paste, dentifrice

FIREFLY Barbie Fluoride Foam Bubblegum Flavor by

Drug Labeling and Warnings

FIREFLY Barbie Fluoride Foam Bubblegum Flavor by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIREFLY Barbie Fluoride Foam Toothpaste Bubblegum Flavor

Active ingredients

Sodium Fluoride 0.243%

Purpose

Anticavity

Use

Helps protect against cavities

Warnings

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

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 physician.
• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
• Shake before use.
• Squirt two times into your mouth and start brushing.
• 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

SPL UNCLASSIFIED SECTION

Liquid Paste Fluoride Foam Toothpaste 

Turn brush time into fun time! It's easy.

Just squirt liquid paste Firefly Foam Toothpaste into your mouth two times and start brushing.

It's much less messy than ordinary toothpaste. No more globs on counter and sink.

As you know, dentists recommend brushing twice a day or after every meal.

And with Firefly Foam Toothpaste your kids will love to brush!  Item # 76-05-76365-24 

DR.FRESH Manufactured and Distributed by:  USA: Dr. Fresh, LLC, Buena Park, CA 90520.  CANADA - Dr. Fresh LLC, Ontario, Canada L7C2T4

PRINCIPAL DISPLAY PANEL

FIREFLY Barbie Fluoride Foam Toothpaste Bubblegum Flavor Made in USA  1.5 FL OZ (45 mL)

FIREFLY Barbie Fluoride Foam Toothpaste Bubblegum Flavor 45ml (

64893-902-45)

INGREDIENTS AND APPEARANCE

FIREFLY BARBIE FLUORIDE FOAM BUBBLEGUM FLAVOR 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-902
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 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)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM (Bubble Gum)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64893-902-45	1 in 1 CARTON	03/01/2013
1		45 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/01/2013

Labeler - Dr. Fresh LLC (117376803)

Registrant - Dr. Fresh LLC (117376803)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Fresh LLC		117376803	manufacture(64893-902)