FIREFLY ANTICAVITY FLUORIDE TOOTH BUBBLEGUM- sodium monofluorophosphate paste
Shanghai Maxam Company Limited

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 Anticavity Fluoride Toopthpaste Bubblegum

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?

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Package Labeling:

Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70448-401-01	1 in 1 BOX	01/29/2016	06/26/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/29/2016	06/26/2019

Labeler - Shanghai Maxam Company Limited (421325329)

Revised: 1/2021

Document Id: b96c632b-9552-f62a-e053-2995a90a9725

Set id: 50c73bb4-9c06-42ae-9d99-cbda1dbbae3c

Version: 4

Effective Time: 20210121

Shanghai Maxam Company Limited