Acetic Acid .25 g/100mL
Acetic Acid · IRRIGANT · B. Braun Medical Inc.
Acetic acid irrigation is a prescription liquid solution used to irrigate wounds and body cavities, helping to cleanse affected areas. It works as a mild antimicrobial agent to help prevent infection during medical procedures or wound care.
Key Facts
- Brand Name
- Acetic Acid
- Generic Name
- Acetic Acid
- NDC Code (Product)
0264-2304- Manufacturer
- B. Braun Medical Inc.
- Strength
- .25 g/100mL
- Dosage Form
- IRRIGANT
- Route
- IRRIGATION
- Marketing Status
- Application #
- NDA018161
- Marketing Start
- 08/06/1979
Recall History
B. Braun Medical Inc
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Actavis Inc
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Akorn Inc
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Taro Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Hi-Tech Pharmacal Co., Inc.
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Akorn Inc
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
Dosage & Administration
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 acetic acid otic 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 drops to 5 drops of acetic acid otic solution every 4 hours to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid otic solution 3 times or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 drops to 4 drops may be sufficient due to the smaller capacity of the ear canal.
Warnings
WARNINGS Discontinue promptly if sensitization or irritation occurs.
Contraindications
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.
Adverse Reactions
ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Acetic Acid used for?
Acetic acid irrigation is a prescription liquid solution used to irrigate wounds and body cavities, helping to cleanse affected areas. It works as a mild antimicrobial agent to help prevent infection during medical procedures or wound care.
Is Acetic Acid a controlled substance?
Acetic Acid is not classified as a controlled substance by the DEA.
What is the generic name for Acetic Acid?
The generic name for Acetic Acid is Acetic Acid. There are 3 other brand versions of Acetic Acid.
What is the NDC code for Acetic Acid .25 g/100mL?
The NDC (National Drug Code) for Acetic Acid .25 g/100mL is 0264-2304, listed by B. Braun Medical Inc..