SMILEY GRIPPER- sodium fluoride paste

Smiley Gripper by

Drug Labeling and Warnings

Smiley Gripper 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

Smiley Gripper
Crest has been shown to be an effective decay-preventative dentifrice that can be of significant value when used as directed in a conscientiously applied program of oral hygiene and regular professional care.
Council on Scientific Affairs - American Dental Association

This product contains no sugar, like all ADA Accepted toothpastes.

The Smiley Gripper toothbrush is specially designed to stick and stand on bathroom counters and sink to avoid contamination.

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.

Crest(R) toothpaste is a product of Procter and Gamble, Cincinnati, OH USA

Distributed by
Dr. Fresh, Inc.
Buena Park, CA 90620 USA

Canada- Dr. Fresh Inc. Ontario Canada L7C2T4
268 Bath Road, Slough, Berkshire SL1 4DX

Questions? Comments? Toll Free:
1-866-373-7374  USA 1-714-690-1573

UK and IRL: +44(0)1753 725365
comments@drfresh.com
visit us online at
www.drfresh.com   www.drfresh.co.uk

Toothpaste and packaging Made in U.S.A.,
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

SMILEY GRIPPER 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-495
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: 64893-495-01	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)