Label: ANTIPYRINE AND BENZOCAINE- antipyrine and benzocaine liquid

  • NDC Code(s): 76439-305-10, 76439-305-15
  • Packager: Virtus Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 09/12

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

  • SPL UNCLASSIFIED SECTION

    NDC# 76439-305-10 (10 mL)

    NDC# 76439-305-15 (15 mL)

    Topical Decongestant and Analgesic

    Rx Only

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  • DESCRIPTION

    Antipyrine and Benzocaine Otic Solution is an otic solution containing Antipyrine, Benzocaine, Oxyquinoline Sulfate, and Anhydrous Glycerin for use in the ear. The solution congeals at 0°C (32°F), but returns to normal consistency, unchanged, at room temperature.

    Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phenyl-3-pyrazolin-5- one. The active ingredient is represented by the structural formula:

    Chemical Structure

    C11H12N2O      MW=188.22

    Antipyrine occurs as colorless crystals or white powder, has a slightly bitter taste and is soluble in water and alcohol.

    Benzocaine is a local anesthetic. It is chemically ethyl p-aminobenzoate or Benzoic acid, 4-amino-, ethyl ester. The active ingredient is represented by the structural formula:

    Chemical Structure

    C9H11NO2      MW=165.19

    It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents.

    EACH mL CONTAINS:

    Actives: Antipyrine 54 mg, Benzocaine 14 mg; Inactives: Glycerine (anhydrous), Oxyquinoline Sulfate.

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  • CLINICAL PHARMACOLOGY

    Antipyrine and Benzocaine Otic Solution combines the hygroscopic property of anhydrous glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and to alleviate pain and discomfort in acute otitis media.

    Antipyrine and Benzocaine Otic Solution does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

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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

    The 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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  • WARNINGS

    FOR USE IN EARS ONLY-NOT FOR USE IN EYES

    Discontinue promptly if sensitization or irritation occurs.

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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 have been conducted.

    Pregnancy

    Category C

    Animal reproduction studies have not been conducted with Antipyrine and Benzocaine Otic Solution. It is also not known whether Antipyrine and Benzocaine Otic Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antipyrine and Benzocaine Otic Solution 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. Because many drugs are excreted in human milk, caution should be exercised when Antipyrine and Benzocaine Otic Solution is administered to a nursing woman.

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  • DOSAGE AND ADMINISTRATION

    Acute otitis media

    Instill Antipyrine and Benzocaine Otic Solution, permitting the solution to run along the wall of the ear canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine and Benzocaine Otic Solution and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.

    Removal of Cerumen

    Before: Instill Antipyrine and Benzocaine Otic Solution three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal.

    After: Antipyrine and Benzocaine Otic Solution is useful for drying out the ear canal or relieving discomfort.

    Before and after removal of cerumen, a cotton pledget moistened with Antipyrine and Benzocaine Otic Solution should be inserted into the meatus following instillation.

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  • HOW SUPPLIED

    Antipyrine and Benzocaine Otic Solution is supplied in a plastic light-resistant dropper-bottle with a screwtop cap containing 10 mL (NDC# 76439-305-10) and 15 mL (NDC# 76439-305-15). Tamper evident seal is on the bottle cap. Do not use if seal is broken.

    Storage and Handling

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat and light. Protect from freezing.

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  • SPL UNCLASSIFIED SECTION

    Call your doctor for medical advice about side effects. You may report side effects to 813-283-1344.

    Manufactured for:
    Virtus Pharmaceuticals, LLC
    Tampa, FL 33619

    Rev. 04/12

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  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    VIRTUS
    PHARMACEUTICALS

    NDC 76439-305-10

    Antipyrine &
    Benzocaine

    Otic Solution, USP

    Each mL Contains the Active Ingredients:

    Antipyrine USP            54 mg
    Benzocaine USP        14 mg

    Rx only
    10 mL
    (1/3 fl. oz.)

    PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    ANTIPYRINE AND BENZOCAINE 
    antipyrine and benzocaine liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-305
    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 14 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin  
    Oxyquinoline Sulfate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76439-305-10 1 in 1 CARTON
    1 10 mL in 1 BOTTLE, DROPPER
    2 NDC:76439-305-15 1 in 1 CARTON
    2 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 09/12/2012
    Labeler - Virtus Pharmaceuticals (969483143)
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