Active Ingredient
Eugenol 1.3% (extracted from Clove Plant)
Nuby Teething Gel
FDA Label NDC 70797-230
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Talbot�s Pharmaceuticals Family Products, Llc. for the product Nuby Teething Gel (NDC 70797-230). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, warnings, directions, inactive ingredients, use, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever
Keep Out Of Reach Of Children
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
Warnings
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
Directions
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.
Inactive Ingredients
Aqua (Water), Betaine, Bioflavonoids, Citric Acid, Flavor (Natural), Glycerin, Glyceryl Caprylate, Glyceryl Undecelynate, Lactic Acid, Potassium Sorbate, Propanediol, Stevia Rebaudiana Extract, Xanthan Gum
Use
For the temporary relief of sore gums due to teething in infants and children 4 months of age and older.
* Please review the disclaimer below.
