Label: OTOZIN- antipyrine, benzocaine and zinc acetate solution 

  • Label RSS
  • NDC Code(s): 28595-420-20
  • Packager: Allegis Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 05/11

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

  • SPL UNCLASSIFIED SECTION

    Rx ONLY

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  • DESCRIPTION

    Each 1 mL for otic administration contains:

    Antipyrine 54 mg
    Benzocaine 10 mg
    Zinc Acetate Dihydrate 10 mg

    Also contains acetic acid, propylene glycol, glycerin, purified water, and vitamin E polyethylene glycol 1000 succinate.

    Antipyrine is an antipyretic and analgesic. Antipyrine occurs as a colorless, almost odorless, crystalline powder or tabular crystals having a slightly bitter taste. It is very soluble in water and freely soluble in alcohol. Chemically its structure is C11H12N20.

    Benzocaine is a short-acting local anesthetic. Benzocaine occurs as a white, crystalline powder. Chemically its structure is C9H11NO2.

    Zinc acetate in the dihydrate form is a salt of zinc and a topical skin protectant generally recognized as safe and effective. Zinc acetate dihydrate occurs as white crystals or granules, is freely soluble in water and in boiling alcohol and is slightly soluble in alcohol. Chemically its structural formula is C4H6O4Zn•2H2O.

    TOPICAL DECONGESTANT, ANALGESIC, & SKIN PROTECTANT

    An otic solution containing antipyrine, benzocaine and zinc acetate dihydrate.

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  • CLINICAL PHARMACOLOGY

    Combines the analgesic action of antipyrine and benzocaine with the skin protectant zinc acetate to relieve pressure, reduce inflammation and congestion, protect the skin, and alleviate pain and discomfort in acute otitis media.

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  • INDICATIONS AND USAGE

    Acute otitis media of various etiologies

    • Prompt relief of pain and reduction of inflammation in the congestive and serous stages.
    • Adjuvant therapy during systemic antibiotic administration for resolution of the infection.

    Because of the close anatomical relationship of the Eustachian tube to the nasal cavity, otitis media is a frequent problem especially in children in whom the tube is shorter, wider and more horizontal than in adults.

    Removal of cerumen

    • Facilitates the removal of excessive or impacted cerumen.
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  • CONTRAINDICATIONS

    This product is contraindicated in any person with hypersensitivity to any of the components or substances related to them. This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.

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  • PRECAUTIONS

    Information for Patients

    Avoid contaminating the dropper with material from the ear, fingers or other source.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No long-term studies in animals or humans have been conducted.

    Pregnancy Category C

    Animal reproduction studies have not been conducted with this preparation. It is also not known whether this product can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Caution should be exercised when this product is administered to a nursing woman.

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  • DOSAGE AND ADMINISTRATION

    Acute otitis media

    Warm to body temperature. Using a single bottle dropper, instill the product permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with the dropper. Repeat every one to two hours until pain and congestion are relieved.

    Removal of cerumen

    Before

    Instill three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.

    After

    This product is useful for drying out the canal or relieving discomfort. Before and after removal of cerumen a cotton pledget moistened with the product should be inserted into the meatus following instillation.

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  • HOW SUPPLIED

    OTOZIN is supplied as a clear liquid delivered in 2 white dropper bottles containing 10 mL each as a single prescription package (NDC 28595-420-20).

    Store at controlled room temperature 68°-77°F (20°-25°C). Protect from light.

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  • SPL UNCLASSIFIED SECTION

    Rx only

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    U.S. Patent # 6,093,417

    Manufactured for:
    Allegis Pharmaceuticals
    Canton, MS 39046

    Rev. 4/2011

    T3.0

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  • PRINCIPAL DISPLAY PANEL - Two 10 mL Bottle Carton

    NDC: 28595-420-20

    Rx ONLY

    otozin
    Antipyrine 5.4%
    Benzocaine 1.0%
    Zinc Acetate Dihydrate 1.0%

    ALLEGIS
    PHARMACEUTICALS

    Canton, MS 39046

    Two 10 mL
    Bottles

    PRINCIPAL DISPLAY PANEL - Two 10 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    OTOZIN 
    antipyrine, benzocaine, and zinc acetate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:28595-420
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Antipyrine (Antipyrine) Antipyrine 54 mg  in 1 mL
    Benzocaine (Benzocaine) Benzocaine 10 mg  in 1 mL
    Zinc Acetate (Zinc) Zinc Acetate 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Propylene Glycol  
    Glycerin  
    Acetic Acid  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:28595-420-20 2 in 1 BOX
    1 10 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 05/06/2011
    Labeler - Allegis Pharmaceuticals, LLC (792272861)
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