Label: HYDROCORTISONE AND ACETIC ACID solution

  • NDC Code(s): 50383-901-10
  • Packager: Hi-Tech Pharmacal Co., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 10, 2018

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  • DESCRIPTION

    Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%) and citric acid (0.05%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are:

    Chemical structuracetic AcidChemical Structure_Hydrocortisone

    Hydrocortisone and 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; hydrocortisone is antiinflammatory, antiallergic and antipruritic; 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, complicated by inflammation.

  • CONTRAINDICATIONS

    Hypersensitivity to Hydrocortisone and Acetic Acid or any of the ingredients; herpes simplex, vaccinia and varicella. 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.

    Pregnancy

    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 Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and 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 Hydrocortisone and 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 Hydrocortisone and 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

    Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 50383-901-10).

  • STORAGE

    Store at room temperature, 20°- 25°C (68°-77°F).

    Keep container tightly closed.

    Rx only

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    Rev. 901:01 5/09

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    carton

    AKORN

    NDC 50383-901-10

    Hydrocortisone and Acetic Acid Otic Solution, USP

    10 mL

    Rx only

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE AND ACETIC ACID 
    hydrocortisone and acetic acid solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50383-901
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID20.75 mg  in 1 mL
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10.375 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50383-901-101 in 1 CARTON06/04/2009
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01277006/04/2009
    Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(50383-901)