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acetic acid (Hi-Tech Pharmacal Co., Inc.)

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SOLUTION 1 BOTTLE in 1 BOX (50383-889-15) > 15 mL in 1 BOTTLE Label Information

Complete acetic acid Information

  • Rx only


  • DESCRIPTION

    Acetic Acid Otic Solution, USP is a solution of acetic acid (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:

    Chemical Structure

    Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.


  • CLINICAL PHARMACOLOGY

    Acetic acid is antibacterial and antifungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.


  • INDICATIONS AND USAGE

    For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.


  • CONTRAINDICATIONS

    Hypersensitivity to acetic acid or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.


  • WARNINGS

    Discontinue promptly if sensitization or irritation occurs.


  • PRECAUTIONS

    Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.


  • PEDIATRIC USE

    Safety and effectiveness in pediatric patients below the age of 3 years have not been established.


  • ADVERSE REACTIONS

    Stinging or burning may be noted occasionally; local irritation has occurred very rarely.


  • DOSAGE AND ADMINISTRATION

    Carefully remove all cerumen and debris to allow acetic acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of acetic acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.


  • HOW SUPPLIED

    Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL (NDC 50383-889-15) measured-drop, safety-tip plastic bottles.


  • STORAGE

    Store at 20°- 25°C (68°-77°F). Keep container tightly closed.

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    Rev. 889:02 11/09


  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Carton

    NDC 50383-889-15

    Acetic Acid Otic Solution, USP

    15 mL

    Rx only


  • INGREDIENTS AND APPEARANCE
    ACETIC ACID 
    acetic acid solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-889
    Route of Administration AURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID 20.65 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50383-889-15 1 in 1 BOX 01/22/2010
    1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA012179 01/22/2010
    Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-889)