FIREFLY ANTICAVITY FLUORIDE- sodium monofluorophosphate paste

FIREFLY AntiCavity Fluoride by

Drug Labeling and Warnings

FIREFLY AntiCavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh, Inc., Changzhou Daya Imp & Exp Corp., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                 Purpose

Sodium Monofluorophosphate 0.76%    Anti-Cavity Toothpaste

PURPOSE

Use: Helps prevent against cavities

KEEP OUT OF REACH OF CHILDREN

Warnings: Keep out of reach of children under 6 years of age.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. Childern 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

AntiCavity Fluoride

  Toothpaste

BLAZIN

Bubble Gum

NET WT

1 OZ (28g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIREFLY ANTICAVITY FLUORIDE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-400
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: 64893-400-01	28 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/03/2010

Labeler - Dr. Fresh, Inc. (033059119)

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