FIREFLY Anticavity Fluoride Tooth Bubblegum

Manufacturer
Shanghai Maxam Company Limited
Effective date
2018-06-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:54:20

Label at a glance#

ProductFIREFLY Anticavity Fluoride Tooth Bubblegum
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Anti-Cavity Toothpaste

Use

INDICATIONS & USAGE SECTION

Helps prevent against cavities

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70448-40170448-401-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b96c632b-9552-f62a-e053-2995a90a972550c73bb4-9c06-42ae-9d99-cbda1dbbae3c2021-01-21WarningsExact identifier
spl set id: 50c73bb4-9c06-42ae-9d99-cbda1dbbae3c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.