BARBIE STRIPED FLUORIDE- sodium fluoride paste, dentifrice

Barbie Striped Fluoride by

Drug Labeling and Warnings

Barbie Striped Fluoride by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Sodium fluoride 0.22%
(0.12% w/v Fluoride Ion, 1000ppm)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

If more than is used for rushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

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)
• Use a pea-sized amount for children under 6
• Supervise children as necessary until capable of using without supervision
• Children under 2 years of age: consult a dentist or physician

Inactive Ingredients

Cellulose Gum, DandC Red No. 30, Flavor, Hydrated Silica, PEG-32, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Trisodium Phosphate, Water.

DESCRIPTION

Smileguard Striped Fluoride Toothpaste

Strawberry Flavored with Barbie has been specially formulated to help protect young children's teeth from decay and strengthen tooth enamel

With fluoride to help:

• Strengthen and remineralize tooth enamel
• Protect against cavities
• Maintain healthygums
• Encourage a healthy dental routine.

More effective cleaning for improved oral hygiene compared to a manual toothbrush.
Smileguard Turbo Power
Battery Powered Toothbrush with Barbie

• Proven to remove more harmvul plaque than any ordinary manual toothbrush
• Effectively cleans between teeht and along gumline
• Helps to prevent gum disease and tooth decay
• As gentle on teeth and gums as a soft manual toothbrush

Warning: Not suitable for children 7 years or under.
Children should be supervised. Should any discomfort occur during use discontinue use immediately. If discomfort continues, please contact your dental professional.

Manufactured and Distributed by
Dr. Fresh Inc.
USA - Dr. Fresh, Inc. Buena Park, CA 90620 USA
Canada - Dr. Fresh, Inc Ontario Canada L7C2T4
UK -Grosvenor Consumer products Ltd (Dr. Fresh, UK)
268 Bath Road, Slough, Berkshire SL14KX UK

Customer service and website info: Questions? Comments?
Toll Free: 1-866-373-7374  comments @dr.fresh.com
USA: 714-690-1573   www.drfresh.com
UK AND IRL: +44-(0)753 725305  www.drfresh.co.uk

Smileguard and related trademarks, names and logos are the property of Dr. Fresh, Inc. and are registered and/or used n the U.S. and countries around the world. 2012 Dr. Fresh, Inc.

Barbie and associated trademarks and trade dress are owned by, and used under license from Mattel, Inc. 2012 Mattel, Inc. All Rights Reserved
barbie.com

Product Labeling

INGREDIENTS AND APPEARANCE

BARBIE STRIPED FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-901
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
D&C RED NO. 30 (UNII: 2S42T2808B)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PHOSPHATE, TRIBASIC, MONOHYDRATE (UNII: J9O85FKF29)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64893-901-01	1 in 1 PACKAGE
1		97.5 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/13/2012

Labeler - Dr. Fresh, Inc. (033059119)