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

Dosage form: gel
Ingredients: EUGENOL 8mg in 1g
Labeler: Talbot’s Pharmaceuticals Family Products, LLC.
NDC Code: 70797-231

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 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.

Use

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

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

Principal Display Panel

NUBY TEETHING GEL 
teething gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70797-231
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUGENOL (EUGENOL) EUGENOL8 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:70797-231-1212 CARTON in 1 CARTON
13 BLISTER PACK in 1 CARTON
11 TUBE in 1 BLISTER PACK
1NDC:70797-231-1515 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/22/2017
Labeler - Talbot’s Pharmaceuticals Family Products, LLC. (078855555)

 
Talbot’s Pharmaceuticals Family Products, LLC.

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Medically reviewed on Jun 23, 2017

Further information

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

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