Label: NUBY TEETHING GEL- teething gel gel

  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 28, 2016

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Eugenol 1.3% (extracted from Clove Plant)

    Active Ingredient

  • 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.

    Keep out of reach of children

  • 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

    Inactive Ingredients

  • Use

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


  • Principal Display Panel

    Principal Display Panel

    teething gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70797-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL13 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    FlavorTUTTI FRUTTIImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70797-230-2424 in 1 CARTON12/01/2016
    14 in 1 CARTON
    11 in 1 BLISTER PACK
    1NDC:70797-230-1515 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    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)