FDA Label for Nuby Teething Gel
View Indications, Usage & Precautions
Nuby Teething Gel Product Label
The following document was submitted to the FDA by the labeler of this product Europharma Concepts Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Eugenol 0.8%
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, Caprylic Acid, Citric Acid, Flavor (Natural), Glycerin, Lactic Acid, Levulinic 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.