FIREFLY PEDIATRIC- sodium monofluorophosphate paste

FIREFLY Pediatric by

Drug Labeling and Warnings

FIREFLY Pediatric by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                               

Sodium Monofluorophosphate 0.76%

PURPOSE

Purpose
Anti-Cavity Toothpaste

INDICATIONS & USAGE

Use: Helps prevent against cavities

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

Questions? Call 1-866-373-7374

www.drfresh.com

DESCRIPTION

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIREFLY PEDIATRIC 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-802
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN (UNII: FST467XS7D)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64893-802-00	1 in 1 POUCH
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/17/2011

Labeler - Dr. Fresh, Inc. (033059119)

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Daya Imp & Exp Corp., Ltd.		421084500	manufacture