FIREFLY ANTICAVITY FLUORIDE TOOTH BUBBLEGUM- sodium monofluorophosphate paste

FIREFLY Anticavity Fluoride Tooth Bubblegum by

Drug Labeling and Warnings

FIREFLY Anticavity Fluoride Tooth Bubblegum by is a Otc medication manufactured, distributed, or labeled by Shanghai Maxam Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts / Instructions

Active Ingredient

Sodium monofluorophosphate 0.76%

Purpose

Anti-Cavity Toothpaste

Use

Helps prevent against cavities

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.

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice a day 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 years: ask a dentist

Inactive Ingredients

Sorbitol, Silica, Water, PEG-32, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Trisodium Phosphate, Mica, Calcium Glycerophosphate, FD&C Blue No.1

Questions? Comments?

Toll Free: 1-866-373-7374 comments@drfresh.com Visit us online at: www.drfresh.com

Package Labeling:

INGREDIENTS AND APPEARANCE

FIREFLY ANTICAVITY FLUORIDE TOOTH BUBBLEGUM 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70448-401
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MICA (UNII: V8A1AW0880)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70448-401-01	1 in 1 BOX	01/29/2016
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/29/2016

Labeler - Shanghai Maxam Company Limited (421325329)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Maxam Company Limited		421325329	manufacture(70448-401)