Label: HYDROCORTISONE AND ACETIC ACID- hydrocortisone and acetic acid solution

  • NDC Code(s): 51672-3007-1
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 12, 2015

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

  • SPL UNCLASSIFIED SECTION

    (Hydrocortisone and Acetic Acid Otic Solution, USP)

    Rx only

    Close
  • DESCRIPTION

    Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.2%), propylene glycol diacetate (3%) and sodium acetate (0.015%).

    Acetic acid has a molecular formula of CH3COOH with molecular weight of 60.05. The structural formula is:

    Chemical Structure

    Acetic Acid

    Hydrocortisone is a Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11β)-. Hydrocortisone has a molecular formula of C21H30O5 with molecular weight 362.46. The structural formula is:

    Chemical Structure

    Hydrocortisone

    Hydrocortisone and acetic acid is available as a non-aqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal.

    Close
  • CLINICAL PHARMACOLOGY

    Acetic acid is anti-bacterial and antifungal; hydrocortisone is anti-inflammatory, 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.

    Close
  • 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.

    Close
  • CONTRAINDICATIONS

    Hypersensitivity to hydrocortisone and acetic acid otic solution 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.

    Close
  • WARNINGS

    Discontinue promptly if sensitization or irritation occurs.

    Close
  • 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.

    Close
  • ADVERSE REACTIONS

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

    Close
  • DOSAGE AND ADMINISTRATION

    Carefully remove all cerumen and debris to allow hydrocortisone 1% and acetic acid 2% 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 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.

    Close
  • HOW SUPPLIED

    Hydrocortisone 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle.

    10 mL bottle NDC 51672-3007-1

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

    Close
  • SPL UNCLASSIFIED SECTION

    Mfd. by: Taro Pharmaceuticals Inc.
    Brampton, Ontario, Canada L6T 1C1
    Dist. by: Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

    Revised: May, 2015

    PK-4785-1
    61
    0515-1

    Close
  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    10 mL

    NDC 51672-3007-1

    Hydrocortisone 1%
    and Acetic Acid 2%
    Otic Solution USP

    FOR OTIC USE ONLY.

    Keep this and all
    medications out of the
    reach of children.

    Rx only

    TARO

    PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
    Close
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE AND ACETIC ACID 
    hydrocortisone and acetic acid solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-3007
    Route of Administration AURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 10.4 mg  in 1 mL
    Acetic Acid (UNII: Q40Q9N063P) (Acetic Acid - UNII:Q40Q9N063P) Acetic Acid 20.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    propylene glycol (UNII: 6DC9Q167V3)  
    propylene glycol diacetate (UNII: 5Z492UNF9O)  
    benzethonium chloride (UNII: PH41D05744)  
    sodium acetate (UNII: 4550K0SC9B)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51672-3007-1 1 in 1 CARTON
    1 10 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 ANDA088759 04/28/2005
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-3007)
    Close