FIREFLY SMILEGUARD KIDS- sodium monofluorophosphate paste

FireFly SmileGuard Kids by

Drug Labeling and Warnings

FireFly SmileGuard Kids by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium monofluorphosphate 0.76%

Purpose

Anticavity toothpaste

Uses

Helps prevent against cavities

Warnings

If more than used for brushing is accidentally swallowed, medical help or contact a poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Do not swallow. To minimize swallowing use a pea-sized amount for children under 6. Supervise children's brushing until good habits are established.

Children under 2 years: Ask a dentist or physician

Inactive Ingredients

Sorbitol, Water, hydrated silica, trisodium phosphate, sodium lauryl sulfate, sodium phosphate, xanthan gum, flavor, sodium saccharin, carbomer 956, mica, titanium dioxide, Blue 1

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DESCRIPTION

USA - Dr. Fresh, Inc.
Buena Park, CA 90620 USA

Canada - Dr. Fresh, Inc.
Ontario, Canada L7C2T4

U.K. Grosvenor Consumer
Products Limited
25 Gore Road, Burnham, Bucks SL18AB

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIREFLY SMILEGUARD KIDS 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-613
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
MICA (UNII: V8A1AW0880)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN (UNII: FST467XS7D)
PHOSPHATE ION (UNII: NK08V8K8HR)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64893-613-01	1 in 1 PACKAGE
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/21/2011

Labeler - Dr. Fresh, Inc. (033059119)