Barbie Striped Fluoride

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 0.22g in 100g
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-901

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Barbie Striped Fluoride Toothpaste

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.

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

BARBIE STRIPED FLUORIDE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-901
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
D&C RED NO. 30 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 1500 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM DIHYDRATE 
SORBITOL 
TITANIUM DIOXIDE 
SODIUM PHOSPHATE, TRIBASIC, MONOHYDRATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:64893-901-011 CONTAINER (CONTAINER) in 1 PACKAGE
197.5 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/13/2012
Labeler - Dr. Fresh, Inc. (033059119)

Revised: 06/2012
 
Dr. Fresh, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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