HELLO KITTY- sodium fluoride paste

Hello Kitty by

Drug Labeling and Warnings

Hello Kitty 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 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?

Dr. Fresh Inc

Buena Park, CA 90620 USA

Toll Free: 1-866-DR-FRESH

Visit us at: www.drfresh.com

DESCRIPTION

Kit Contains:
Hello Kitty Jr. Suction Cup Toothbrush
Hello Kitty Toothbrush cover
Crest Kids toopaste
Hello Kitty 4pack Flossers
Reusable Zip pouch

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

Dr. Fresh Dailies and related trademarks, names, logos and patents are the proerty of  Dr. Fresh Inc and are registered and/or used in the U.S. and countries around the world (c) 2010 Dr. Fresh, Inc. Patent Pending

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. Do not let kids chew or pull apart rubber end.

Hello Kitty by Sanrio
(c) 1976. 2010 Sanrio Co., Ltd
Used Under License
www.sanrio.com


Manufactured and Distributed by
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

Questions? Comments? Toll Free:
1-866-373-7374
comments@drfresh.com
visit uS at
www.drfresh.com   www.drfresh.co.uk

MADE IN P.R.C.


Toothbrush made in PRC

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) 2011 Dr. Fresh, Inc. Patent Pending

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HELLO KITTY 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-310
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: 64893-310-01	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	06/20/2011

Labeler - Dr. Fresh, Inc. (033059119)