FDA.reportPublic FDA data

60 Second Gel Orange Cream

Manufacturer
Germiphene Corporation
Effective date
2017-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:54

Label at a glance#

Product60 Second Gel Bubblegum
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Shake well before using. Fill Germiphene brand disposable trays to appropriate level. After prophylaxis, air dry teeth and insert trays for one minute. Remove trays and have patient expectorate excess gel.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

1.23% fluoride ion from sodium fluoride and hydrofluoric acid. Optimized low pH for a complete fluoride treatment in 60 seconds.

Medicinal Ingredient:

OTC - ACTIVE INGREDIENT SECTION

1.23% fluoride ion

Non-medicinal ingredients:

INACTIVE INGREDIENT SECTION

Water, glycerin, sodium saccharin, methyl paraben, potassium sorbate, phosphoric acid, hydrofluoric acid, acrylic polymer, silicon dioxide, zanthan gum, polysorbate 80 & flavoring agents.

Directions:

DOSAGE & ADMINISTRATION SECTION

Shake well before using. Fill Germiphene brand disposable trays to appropriate level. After prophylaxis, air dry teeth and insert trays for one minute. Remove trays and have patient expectorate excess gel.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Warning/Caution:

WARNINGS SECTION

Do not eat, drink, or rinse for 30 minutes after treatment. Do not use if tamper-evident seal is broken. Do not store in direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 Second Gel Orange Cream60 Second Gel Orange Cream60 Second Gel Mint60 Second Gel Mint60 Second Gel Grape60 Second Gel Grape60 Second Gel Bubblegum60 Second Gel Bubblegum60 Second Gel Strawberry60 Second Gel Strawberry

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61508-0163-12020-01-31C16284748780-19d75b9d1-0543-f424-e053-dadaa90a57ce60 Second Gel
61508-0165-12020-01-31C16284748780-19d75b9d1-0543-f424-e053-dadaa90a57ce60 Second Gel
61508-0166-12020-01-31C16284748780-19d75b9d1-0543-f424-e053-dadaa90a57ce60 Second Gel
61508-0167-12020-01-31C16284748780-19d75b9d1-0543-f424-e053-dadaa90a57ce60 Second Gel
61508-0169-12020-01-31C16284748780-19d75b9d1-0543-f424-e053-dadaa90a57ce60 Second Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61508-0163-160 Second Gel Bubblegum450 g in 1 BOTTLE, PLASTICGEL, DENTIFRICE4501
61508-0165-160 Second Gel Grape450 g in 1 BOTTLE, PLASTICGEL, DENTIFRICE4501
61508-0166-160 Second Gel Mint450 g in 1 BOTTLE, PLASTICGEL, DENTIFRICE4501
61508-0167-160 Second Gel Orange Cream450 g in 1 BOTTLE, PLASTICGEL, DENTIFRICE4501
61508-0169-160 Second Gel Strawberry450 g in 1 BOTTLE, PLASTICGEL, DENTIFRICE4501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61508-016360 SECOND GEL BUBBLEGUM (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL STRAWBERRY (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL GRAPE (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL MINT (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL ORANGE CREAM (FLUORIDE GEL) GEL, DENTIFRICE [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170224_487f6aa0-be7d-39f8-e054-00144ff88e88.zip
61508-016560 SECOND GEL BUBBLEGUM (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL STRAWBERRY (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL GRAPE (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL MINT (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL ORANGE CREAM (FLUORIDE GEL) GEL, DENTIFRICE [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170224_487f6aa0-be7d-39f8-e054-00144ff88e88.zip
61508-016660 SECOND GEL BUBBLEGUM (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL STRAWBERRY (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL GRAPE (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL MINT (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL ORANGE CREAM (FLUORIDE GEL) GEL, DENTIFRICE [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170224_487f6aa0-be7d-39f8-e054-00144ff88e88.zip
61508-016760 SECOND GEL BUBBLEGUM (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL STRAWBERRY (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL GRAPE (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL MINT (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL ORANGE CREAM (FLUORIDE GEL) GEL, DENTIFRICE [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170224_487f6aa0-be7d-39f8-e054-00144ff88e88.zip
61508-016960 SECOND GEL BUBBLEGUM (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL STRAWBERRY (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL GRAPE (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL MINT (FLUORIDE GEL) GEL, DENTIFRICE 60 SECOND GEL ORANGE CREAM (FLUORIDE GEL) GEL, DENTIFRICE [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170224_487f6aa0-be7d-39f8-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61508-016361508-0163-1
61508-016961508-0169-1
61508-016561508-0165-1
61508-016661508-0166-1
61508-016761508-0167-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 61 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PHOSPHORIC ACIDE4GA8884NNIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HYDROFLUORIC ACIDRGL5YE86CZIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PHOSPHORIC ACIDE4GA8884NNIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HYDROFLUORIC ACIDRGL5YE86CZIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PHOSPHORIC ACIDE4GA8884NNIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HYDROFLUORIC ACIDRGL5YE86CZIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PHOSPHORIC ACIDE4GA8884NNIACT

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
487f6aa0-be7e-39f8-e054-00144ff88e88487f6aa0-be7d-39f8-e054-00144ff88e882017-02-14WarningsExact identifier
spl id: 487f6aa0-be7e-39f8-e054-00144ff88e88
spl set id: 487f6aa0-be7d-39f8-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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