SPIDER SENSE SPIDER-MAN PEDIATRIC- sodium fluoride paste

Spider Sense Spider-Man Pediatric by

Drug Labeling and Warnings

Spider Sense Spider-Man Pediatric 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 fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Uses

Helps prevent against cavities

Warnings

If more than used for brushing is accidentally swallowed, get 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  as directed by a dentist or physician. Do not swallow

To minimize swallowing use a pea-sized amount in children under 6.

Supervise children's brushing until good habits are established.

Children under 2 years: Ask a dentist

Inactive Ingredients

Sorbitol, water, hydrated silica, trisodium phosphate, sodium lauryl sulfate, flavor, sodium phosphate, xanthan gum, carbomer 956, sodium saccharin, titanium dioxide, blue no. 1

Comments? Questions?

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DESCRIPTION

Kit Contains:
Spider-man Jr. Suction Cup Toothbrush
Spider-manToothbrush cover
Crest Kids toopaste
Firefly 4pack Flossers
4 Spider-man stickers
Reusable Zip pouch

Crest(R) toothpaste is a product of Procter and Gamble, Cincinnati, OH USA
Toothpaste and packaging Made in U.S.A.,

FireFly and related trademarks, names, logos and patents are the property of  Dr. Fresh Inc and are registered and/or used in the U.S. and countries around the world (c) 2010 Dr. Fresh, Inc. US Patent No D594,157

SmileGuard and related trademarks, names, logos and patents are the property of  Dr. Fresh Inc and are registered and/or used in the U.S. and countries around the world (c) 2010 Dr. Fresh, Inc. Des. Patent No D617,564

CAUTION/CHOKING HAZARD: This product is not a toy and should always be used with adult supervision. Not intended for children under 3 years of age.

MARVEL
Marven, Spider-sense Spider-Man:
TM and 2010 Marvel
Entertainment, LLC
and its subsidiaries. Licensed by Marvel Characters B.V.
www.marvel.com
All rights reserved.


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

Canada- Dr. Fresh Inc. Ontario Canada L7C2T4

U.K. - Grosvenor Cunsumer Products Limited
25 Gore Road, Burnham Buks SL18AB

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPIDER SENSE SPIDER-MAN PEDIATRIC 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-331
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.243 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PHOSPHATE ION (UNII: NK08V8K8HR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64893-331-01	1 in 1 PACKAGE
1		24 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)