Sodium Fluoride 1.1% Dental Gel BUBBLEGUM

Manufacturer
IPG PHARMACEUTICALS, INC.
Effective date
2025-07-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:37:17

Label at a glance#

ProductSodium Fluoride 1.1% Dental Gel BUBBLEGUM
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.

Dosage and administration

Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician. Adults and Children 6 Years of Age and Older : Twist off cap and remove foil seal. Apply at least a1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth. Dosage form an...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

1.1% neutral sodium fluoride

OTC - PURPOSE SECTION

Sodium Fluoride Dental Gel 1.1% is a flavored, pH neutral 1.1% sodium fluoride that aids in the prevention of dental decay and helps to treat sensitive teeth.

Uses

INDICATIONS & USAGE SECTION

This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.

Directions

DOSAGE & ADMINISTRATION SECTION

Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician.

Adults and Children 6 Years of Age and Older: Twist off cap and remove foil seal. Apply at least a1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly. Make sure to brush all
sensitive areas of the teeth.

Dosage form and Strengths: Dental gel containing 1.1% sodium fluoride.

Warning

WARNINGS SECTION

Contraindications: Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 6 unless directed by a dentist or physician.
Warnings and Precautions: Do no swallow. Keep out of reach of children. Read the prescribing information fully before using this product. If the product is accidentally swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Adverse reactions: To report suspected

Adverse reactions, To report suspected adverse reactions, contact IPG Pharmaceuticals at (888) 711-7116 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

Inactive ingredient 

INACTIVE INGREDIENT SECTION

Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Sorbitol, Xanthan Gum, Flavor, Yucca Shidigera Root Extract, Quillaja
Saponaria Bark Extract, Smilax Aristolochiaefolia Root Extract, Dioscorea Villosa Root Extract, Tocopheryl Acetate, Cocamidopropyl Betaine,
Benzyl Alcohol.

SPL UNCLASSIFIED SECTION

How Supplied/Storage: 7.4 oz (200gm) in plastic tube. Store at room temperature 59-86°F (15-30°C)

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1486566sodium fluoride 1.1 % Oral GelPSN1
1486566sodium fluoride 0.011 MG/MG Oral GelSCD1
1486566sodium fluoride 1.1 % Oral GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71085-079-02Sodium Fluoride 1.1% Dental Gel BUBBLEGUM1 in 1 CARTONGEL11
71085-079-02Sodium Fluoride 1.1% Dental Gel BUBBLEGUM200 g in 1 TUBEGEL2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-079-02GM - Gram71085-0793f4a0c9e-046d-403c-be64-51b79cc1518112025-08-11

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71085-07971085-079-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
58648ec8-6532-50e3-e063-6394a90af0cf5fb07d97-ce03-416f-a4a2-75c23cfebc052026-08-06WarningsExact identifier
spl set id: 5fb07d97-ce03-416f-a4a2-75c23cfebc05

Reported adverse events (FAERS/openFDA)#

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