Nuby Teething Gel

Manufacturer
Europharma Concepts limited
Effective date
2017-06-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:51:45

Label at a glance#

ProductNuby Teething Gel
Active ingredientEUGENOL
Label structure8 sections

Dosage and administration

Wash hands before use. Cut open tip of tube on score mark. Use your finger tip or cotton applicator to gently apply a small pea-size amount of Nuby Teething Gel to the affected area up to 4 times daily or as directed by a physician or healthcare provider. For infants under 4 months of age, ask a dentist or doctor before use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Eugenol 0.8%

active ingredientactive ingredient

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

PurposePurpose

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Keep out of reach of childrenKeep out of reach of children

Warnings

WARNINGS SECTION

Allergy alert do not use this product if your baby has a history of allergy to clove, its component eugenol, or to Balsam of Peru.

Do not use

more than directed

for more than 7 days unless directed by a dentist or doctor

When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician.

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days

irritation, pain or redness does not go away

swelling, rash or fever develops

warningswarnings

Directions

DOSAGE & ADMINISTRATION SECTION

Wash hands before use.

Cut open tip of tube on score mark.

Use your finger tip or cotton applicator to gently apply a small pea-size amount of Nuby Teething Gel to the affected area up to 4 times daily or as directed by a physician or healthcare provider.

For infants under 4 months of age, ask a dentist or doctor before use.

Dosage & AdministrationDosage & Administration

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Betaine, Bioflavonoids, Caprylic Acid, Citric Acid, Flavor (Natural), Glycerin, Lactic Acid, Levulinic Acid, Potassium Sorbate, Propanediol, Stevia Rebaudiana Extract, Xanthan Gum

inactive ingredientinactive ingredient

Use

INDICATIONS & USAGE SECTION

For the temporary relief of sore gums due to teething in infants and children 4 months of age and older.

UseUse

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1926568eugenol 0.8 % Oral GelPSN2
1926568eugenol 0.008 MG/MG Oral GelSCD2
1926568eugenol 0.8 % Oral GelSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EUGENOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71552-231-122020-01-31C16284748780-19d75b9d0-32e3-f424-e053-dadaa90a57ce53082bd5-12df-6587-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71552-231-12Nuby Teething Gel3 in 1 CARTONGEL32
71552-231-12Nuby Teething Gel12 in 1 CARTONGEL122
71552-231-15Nuby Teething Gel15 g in 1 TUBEGEL152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71552-231NUBY TEETHING GEL (TEETHING GEL) GEL [EUROPHARMA CONCEPTS LIMITED]2Legacy NDC, 3 package rows20170628_53082bd5-12df-6587-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71552-23171552-231-15, 71552-231-12

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EUGENOL3T8H1794QWACTIB

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
52a6d991-fefc-3df2-e054-00144ff8d46c53082bd5-12df-6587-e054-00144ff88e882017-06-23WarningsExact identifier
spl id: 52a6d991-fefc-3df2-e054-00144ff8d46c
spl set id: 53082bd5-12df-6587-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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