Label: ACETIC ACID- acetic acid solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 2, 2019

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

  • 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.

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  • 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.

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  • INDICATIONS AND USAGE

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

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  • 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.

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  • WARNINGS

    Discontinue promptly if sensitization or irritation occurs.

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  • PRECAUTIONS

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

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  • PEDIATRIC USE

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

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  • ADVERSE REACTIONS

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

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  • 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.

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  • HOW SUPPLIED

    Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL (NDC 68788-7231-1) measured-drop, safety-tip plastic bottles.

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  • 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

    Relabeled By: Preferred Pharmaceuticals Inc.

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Acetic Acid Solution 2 perecent

    NDC 68788-7231-1

    Acetic Acid Otic Solution, USP

    15 mL

    Rx only

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  • INGREDIENTS AND APPEARANCE
    ACETIC ACID 
    acetic acid solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7231(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:68788-7231-1 1 in 1 BOX 08/06/2018
    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 08/06/2018
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-7231)
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