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Acetasol HC (Actavis Mid Atlantic LLC)

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SOLUTION 1 BOTTLE in 1 CARTON (0472-0882-82) > 10 mL in 1 BOTTLE Label Information

Complete Acetasol HC Information

  • 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 (0.2%). The molecular formulas for acetic acid and hydrocortisone are C2H4O2 and C21H30O5, with molecular weights of 60.05 and 362.46, respectively. The structural formulas are:

    e3717ad1-figure-01

    Chemically, hydrocortisone is: Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-(11ß)-.

    e3717ad1-figure-02

    This product is available as a nonaqueous otic solution buffered at pH 2 to 4 for use in the external ear canal.


  • CLINICAL PHARMACOLOGY

    Acetic acid is anti-bacterial and anti-fungal; hydrocortisone is anti-inflammatory, anti-allergic and anti-pruritic; 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 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.

    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 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 solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of 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.


  • HOW SUPPLIED

    Hydrocortisone and Acetic Acid Otic Solution USP, 1%/2% is available in a 10 mL measured-drop, safety-tip plastic bottle.

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

    Keep container tightly closed.


    Manufactured by:
    Actavis Mid Atlantic LLC
    1877 Kawai Road
    Lincolnton, NC 28092 USA

    FORM NO. 0882
    Rev. 3/08
    VC3300


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ACETASOL HC 
    hydrocortisone and acetic acid solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0882
    Route of Administration AURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1.1 g  in 100 mL
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID 2.41 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0472-0882-82 1 in 1 CARTON 09/10/2002
    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 ANDA087143 09/10/2002
    Labeler - Actavis Pharma, Inc. (119723554)