FIREFLY PEDIATRIC- sodium monofluorophosphate paste 
Dr. Fresh, LLC

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.

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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

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FIREFLY PEDIATRIC 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-802
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN (UNII: FST467XS7D)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64893-802-001 in 1 POUCH08/17/2011
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/17/2011
Labeler - Dr. Fresh, LLC (117376803)

Revised: 11/2021
Document Id: ae6a8dab-74bb-4f42-87cb-5befc1008d20
Set id: fc6df0ff-6cd6-4ee4-b5e0-53771a02cb60
Version: 3
Effective Time: 20211109
 
Dr. Fresh, LLC