Hydrocortisone and Acetic Acid

HYDROCORTISONE AND ACETIC ACID- hydrocortisone and acetic acid solution
Actavis Pharma, Inc.

Rx Only

DESCRIPTION

Hydrocortisone and Acetic Acid Otic Solution USP, is a solution containing hydrocortisone USP, (1%) and acetic acid USP, (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, USP and hydrocortisone, USP are C2 H4 O2 and C21 H30 O5 , with molecular weights of 60.05 and 362.46, respectively. The structural formulas are:

38825c0b-figure-01

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

38825c0b-figure-02

Acetic Acid, USP

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 (NDC 45963-412-61).

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

Keep container tightly closed.

Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised — March 2016

365I602-1180 GW7077

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydro carton
(click image for full-size original)
HYDROCORTISONE AND ACETIC ACID
hydrocortisone and acetic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-412
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1.1 g in 100 mL
ACETIC ACID (ACETIC ACID) ACETIC ACID 2.41 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
BENZETHONIUM CHLORIDE
SODIUM ACETATE
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-412-61 1 BOTTLE in 1 CARTON contains a BOTTLE
1 10 mL in 1 BOTTLE This package is contained within the CARTON (45963-412-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087143 06/29/2009
Labeler — Actavis Pharma, Inc. (119723554)
Establishment
Name Address ID/FEI Operations
G&W NC Laboratories, LLC 079419931 ANALYSIS (45963-412), LABEL (45963-412), MANUFACTURE (45963-412), PACK (45963-412)

Revised: 03/2016 Actavis Pharma, Inc.

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