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FireFly SmileGuard Kids

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-613

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.

FireFly SmileGuard Kids Kit

Active Ingredient

Sodium monofluorphosphate 0.76%

Purpose

Anticavity toothpaste

Uses

Helps prevent against cavities

Warnings

If more than used for brushing is accidentally swallowed, 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 or use 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 or physician

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

Comments? Questions?Toll Free: 1-866-373-7374
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USA - Dr. Fresh, Inc.
Buena Park, CA 90620 USA

Canada - Dr. Fresh, Inc.
Ontario, Canada L7C2T4

U.K. Grosvenor Consumer
Products Limited
25 Gore Road, Burnham, Bucks SL18AB


FIREFLY SMILEGUARD KIDS 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-613
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
SILICON DIOXIDE 
WATER 
SODIUM LAURYL SULFATE 
POLYETHYLENE GLYCOL 1500 
MICA 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN 
PHOSPHATE ION 
FD&C BLUE NO. 1 
CALCIUM GLYCEROPHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:64893-613-011 TUBE (TUBE) in 1 PACKAGE
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/21/2011
Labeler - Dr. Fresh, Inc. (033059119)

Revised: 06/2011
 
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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