Label: ACETIC ACID - acetic acid solution

  • NDC Code(s): 64980-424-15
  • Packager: Rising Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 19, 2018

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

  • DESCRIPTION

    Acetic Acid Otic Solution USP is a nonaqueous solution of glacial acetic acid, USP (2%), in a propylene glycol vehicle containing benzethonium chloride, USP (0.02%); propylene glycol diacetate, NF (3%) and sodium acetate, USP (0.015%). It may also contain citric acid, USP.

    The molecular formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:

    structure

    Acetic Acid Otic Solution 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 anti-bacterial and anti-fungal; 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 Otic Solution 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.

    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 Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution 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 the solution 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 Otic Solution 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, 2% is available in 15 mL (NDC 64980-424-15) measured-drop, safety- tip plastic bottles.

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  • STORAGE

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

    KEEP CONTAINER TIGHTLY CLOSED

    Rx Only

    Manufactured by:
    Bio-Pharm, Inc.
    Levittown, PA 19057

    Distributed by:
    Rising Pharmaceuticals, Inc.
    Saddle Brook, NJ 07663

    Rev. 05/2018

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  • PRINCIPAL DISPLAY PANEL - 15 mL bottle

    Rising®

    NDC 64980-424-15

    Acetic Acid Otic

    Solution USP, 2%

    DO NOT USE IF BAND PRINTED
    "SEALED FOR YOUR PROTECTION”
    AROUND CAP IS BROKEN OR MISSING.

    15 mL

    Rx only

    bottle

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  • PRINCIPAL DISPLAY PANEL - 15 mL Carton

    Rising®


    NDC 64980-424-15


    Acetic Acid


    Otic Solution


    USP, 2%


    DO NOT USE IF BAND


    PRINTED "SEALED FOR


    YOUR PROTECTION"


    AROUND CAP IS BROKEN


    OR MISSING"


    15mL


    Rx only


    carton


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  • INGREDIENTS AND APPEARANCE
    ACETIC ACID 
    acetic acid solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-424
    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 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64980-424-15 1 in 1 CARTON 03/14/2018
    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
    ANDA ANDA207280 03/14/2018
    Labeler - Rising Pharmaceuticals, Inc. (041241766)
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