NUBY TEETHING GEL (TEETHING GEL) GEL [EUROPHARMA CONCEPTS LIMITED]

NUBY TEETHING GEL (TEETHING GEL) GEL [EUROPHARMA CONCEPTS LIMITED]
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NDC 71552-231-12, 71552-231-15
Set ID 53082bd5-12df-6587-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Europharma Concepts limited
Generic Name
Product Class
Product Number
Application Number PART356
  • Active Ingredient

    Eugenol 0.8%

    active ingredient

  • Purpose

    Oral pain reliever

    Purpose

  • 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

    warnings

  • 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

  • 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

  • Use

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

    Use

  • Principal Display Panel

    PDP

  • INGREDIENTS AND APPEARANCE
    NUBY TEETHING GEL 
    teething gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71552-231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL8 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71552-231-1212 in 1 CARTON06/28/2017
    13 in 1 CARTON
    11 in 1 BLISTER PACK
    1NDC:71552-231-1515 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/28/2017
    Labeler - Europharma Concepts limited (896333478)

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