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Nuby Teething Gel by Talbot’s Pharmaceuticals Family Products, LLC.

Medically reviewed on June 28, 2018

Dosage form: gel
Ingredients: EUGENOL 13mg in 1g
Labeler: Talbot’s Pharmaceuticals Family Products, LLC.
NDC Code: 70797-230

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Eugenol 1.3% (extracted from Clove Plant)

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.

Principal Display Panel

NUBY TEETHING GEL 
teething gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70797-230
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUGENOL (EUGENOL) EUGENOL13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70797-230-2424 CARTON in 1 CARTON
14 BLISTER PACK in 1 CARTON
11 TUBE in 1 BLISTER PACK
1NDC:70797-230-1515 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/01/2016
Labeler - Talbot’s Pharmaceuticals Family Products, LLC. (078855555)

 
Talbot’s Pharmaceuticals Family Products, LLC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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