Label: NUBY TEETHING GEL- teething gel gel

  • NDC Code(s): 71552-231-12, 71552-231-15
  • Packager: Europharma Concepts limited
  • Category: HUMAN OTC DRUG LABEL
  • 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 23, 2017

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

  • Active Ingredient

    Eugenol 0.8%

    active ingredient

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  • Purpose

    Oral pain reliever

    Purpose

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  • 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

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  • 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

    warnings

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  • 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.

    Dosage & Administration

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  • 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

    inactive ingredient

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  • Use

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

    Use

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    NUBY TEETHING GEL 
    teething gel gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71552-231
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL 8 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71552-231-12 12 in 1 CARTON 06/28/2017
    1 3 in 1 CARTON
    1 1 in 1 BLISTER PACK
    1 NDC:71552-231-15 15 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 06/28/2017
    Labeler - Europharma Concepts limited (896333478)
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