Label: ORTIZOL OTIC SOLUTION- antipyrine, benzocaine, phenylephrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated February 5, 2015

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  • Each ml contains:

    Antipyrine USP 50 mg

    Benzocaine USP 50 mg

    Phenylephrine HCL USP 1.25 mg

  • PURPOSE

    The analgetic action of antipyrine and

    benzocaine to relief pressure. reduce

    inflammation and congestion. and allevate

    pain and discomfort in acute otitis media.

  • INDICATIONS & USAGE

    For the relief of pain and the reduction of

    inflammation in acute otitis media. It is also

    useful in the removal of excessive or

    impacted cerumen.

  • WARNINGS

    Hipersensitivity to any of the components or

    substances related to them. In the presence

    of spontaneous perforation or discharge.

  • DO NOT USE

  • ASK DOCTOR/PHARMACIST

  • WHEN USING

  • PREGNANCY OR BREAST FEEDING

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Warm to body temperature and fill the ear

    canal with 2 to 4 drops. Moisten cotton

    pledget with the solution and gently insert

    into the ear canal.

    Repeat 3 or 4 times daily.

  • OTHER SAFETY INFORMATION

    Store at controlled

    room temperature 25 °C

    (77 ºF).

    Protect from freezing.

    Keep tightly closed.

    Keep this and all

    medications out of reach

    of children.

  • INACTIVE INGREDIENT

    Sodium

    Metabisulfite NF 1 mg.

    Propylene Glycol USP

    897.75 mg.

  • QUESTIONS

  • PRINCIPAL DISPLAY PANEL

    ortizol

  • INGREDIENTS AND APPEARANCE
    ORTIZOL  OTIC SOLUTION
    antipyrine, benzocaine, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61841-180
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANTIPYRINE (UNII: T3CHA1B51H) (ANTIPYRINE - UNII:T3CHA1B51H) ANTIPYRINE50 mg  in 1 mL
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61841-180-051 in 1 CARTON12/19/2014
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/19/2014
    Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
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