SmileGuard Just 4 Me

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.243g in 100g
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-800

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.

SmileGuard Just 4 Me Kit

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anti-cavity 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 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 for 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, Sodium Phosphate, Xanthan Gum, Flavor, Sodium Saccharin, Carbomer 956, Mica, Titanium Dioxide, Blue 1

Distributed / Questions? Comments?

Distributed by:

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 SL1 4DX, UK



Questions? Comments?

Toll Free: 1-866-373-7374

USA:+1-714-690-1573

UK IRL:+

Visit us at: www.drfresh.com

Visit us online at:

www.drfresh.com

www.drfresh.co.uk



The ADA council on Scientific Affairs Acceptance of Just 4 Me Toothbrush is based on its finding that the product its effective for removing plague and helping to prevent or reduce gingivitis, when used as directed.


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.

Just 4 Me, 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. 2011

Crest Toothpaste is a product of Product and Gamble Cincinnati, OH

SmileGuard

just 4 me

Let's Make Travel Fun!

Kit Contains:
  • Suction Cup Toothbrush
  • Crest Kid's Toothpaste
  • Fun Sticker
  • Reusable Zip Pouch
Toothbrush designed for children:
  • Soft bristles, rubber grip handle and suction cup to stand upright
  • Replace toothbrush every 3 months
  • Always use with adult supervision
Directions:
Enjoy the fun with these fun stickers! Decorate and design your pouch, lunchbox and any personal items with adult supervision.

Just 4 You!
Write your name on the name frame sticker with a permanent marker.



SMILEGUARD JUST 4 ME 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-800
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
PHOSPHATE ION 
SODIUM LAURYL SULFATE 
SODIUM PHOSPHATE 
XANTHAN GUM 
SACCHARIN SODIUM 
MICA 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:64893-800-011 TUBE (TUBE) in 1 POUCH
124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/17/2011
Labeler - Dr. Fresh, Inc. (033059119)
Establishment
NameAddressID/FEIOperations
The Procter & Gamble Manufacturing Company007130032manufacture

Revised: 08/2011
 
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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