Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)
NuCare Pharmaceuticals,Inc.
ACETIC ACID
ACETIC ACID 25 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION DRUG
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. Hypersensitivity to Acetic Acid Otic Solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.
Acetic Acid Otic Solution USP, 2% is supplied in 15 mL measured drop, safety-tip plastic bottles. NDC68071-3304-5 Bottle of 15mL Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP CONTAINER TIGHTLY CLOSED
Abbreviated New Drug Application
ACETIC ACID- ACETIC ACID SOLUTION NUCARE PHARMACEUTICALS,INC. ---------- ACETIC ACID OTIC SOLUTION USP, 2% DESCRIPTION Acetic Acid Otic Solution, USP is a nonaqueous solution of glacial acetic acid, USP (2%), in a propylene glycol vehicle containing benzethonium chloride, USP (0.02%); propylene glycol diacetate, NF (3%) and sodium acetate, USP (0.015%). IT MAY ALSO CONTAIN citric acid, USP. The molecular formula for acetic acid is CH COOH, with a molecular weight of 60.05. The structural formula is: Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. CLINICAL PHARMACOLOGY Acetic acid is anti-bacterial and anti-fungal; 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. CONTRAINDICATIONS Hypersensitivity to Acetic Acid Otic Solution or any of the ingredients. 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. 3 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 Acetic Acid 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 addin Read the complete document