FIREFLY Pediatric

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-802

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 Pediatric Kit

Active Ingredient                               

Sodium Monofluorophosphate 0.76%

Purpose
Anti-Cavity Toothpaste

Use: Helps prevent against cavities

 Keep out of reach of children under 6 years of age.

Warnings: If you accidentally swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

Directions: adults and children 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist

Inactive Ingredients: Sorbitol, Silica, Water, Sodium Lauryl Sulfate, Flavor, PEG-32, Mica, Sodium Carboxy Methyl Cellulose, Saccharin, Trisodium Phosphate, FDandC Blue No. 1, Calcium Glycerophosphate

Questions? Call 1-866-373-7374

www.drfresh.com

DR.Fresh

USA - Dr.Fresh Inc.,                      CA - Dr.Fresh Inc.,

Buena Park,CA 90620 USA          Ontario,Canada L7C2T4

U.K. - Dr.Fresh UK LTD.                 "FireFly" and related

Winchester House, London,           trademark are owned by

            NW1 5RA                             Dr.Fresh Inc., U.S.A

FIREFLY

Kids Comply With Firefly!

Pediatric Kit

Premium Zip Pouch

Contains:
  • FireFly Lightup Timer Toothbrush
  • FireFly Bubble Gum Toothpaste
  • FireFly Flossers
  • Toothbrush Cap
Be sure to brush 1 minute on top teeth and 1 minute on bottom teeth








FIREFLY PEDIATRIC 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-802
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 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN 
FD&C BLUE NO. 1 
CALCIUM GLYCEROPHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:64893-802-001 TUBE (TUBE) in 1 POUCH
128 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
Changzhou Daya Imp & Exp Corp., Ltd.421084500manufacture

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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