Label: ACETIC ACID- acetic acid solution
- NDC Code(s): 68788-7231-1
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 50383-889
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated May 2, 2019
If you are a consumer or patient please visit this version.
- Rx only
Acetic Acid Otic Solution, USP is a solution of acetic acid (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:
Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.Close
- CLINICAL PHARMACOLOGY
Acetic acid is antibacterial and antifungal; 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.Close
Hypersensitivity to acetic acid or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.Close
Discontinue promptly if sensitization or irritation occurs.Close
Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.Close
- 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 acetic acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid 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 acetic acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid 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
Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL (NDC 68788-7231-1) measured-drop, safety-tip plastic bottles.Close
Store at 20°- 25°C (68°-77°F). Keep container tightly closed.
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Rev. 889:02 11/09
Relabeled By: Preferred Pharmaceuticals Inc.Close
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Acetic Acid Otic Solution, USP
- INGREDIENTS AND APPEARANCE
acetic acid solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7231(NDC:50383-889) Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID 20.65 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZETHONIUM CHLORIDE (UNII: PH41D05744) PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O) SODIUM ACETATE (UNII: 4550K0SC9B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7231-1 1 in 1 BOX 08/06/2018 1 15 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 NDA NDA012179 08/06/2018 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-7231)