VoSoL HC (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 CH ₃ COOH and C ₂₁ H ₃₀ O ₅ , with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are:

VoSoL HC is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

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.

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 VoSoL HC or any of the ingredients; herpes simplex, vaccinia and varicella. Performated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

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 VoSoL HC to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with VoSoL HC 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 VoSoL HC every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of VoSoL HC 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

VoSoL HC (Hydrocortisone and acetic acid otic solution, USP), containing hyrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 0037-3811-12).

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

WALLACE LABORATORIES

Division of CARTER-WALLACE, INC.

Cranbury, New Jersey 08512

IN-056H9-05D  Rev. 12/97