Acetic Acid

• 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.contraindicated

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.

Discontinue promptly if sensitization or irritation occurs.

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.

• Jun 23, 1961NDANDA012770Saptalis Pharms
• Aug 6, 1979NDANDA018161B Braun
• Feb 19, 1982NDANDA018523Baxter Hlthcare
• Mar 4, 1985ANDAANDA088759Taro
• Jul 26, 1996ANDAANDA040166Chartwell Rx
• Feb 24, 2005ANDAANDA040607Sciegen Pharms
• Feb 6, 2006ANDAANDA040609Cosette

1. 1Nausea3710%
2. 2Diarrhoea297.8%
3. 3Toxicity To Various Agents287.6%
4. 4Pain267.0%
5. 5Cough246.5%
6. 6Dyspnoea246.5%
7. 7Drug Ineffective225.9%
8. 8Arthralgia215.7%
9. 9Off Label Use215.7%
10. 10Coronary Artery Disease205.4%
11. 11Dizziness195.1%
12. 12Fatigue195.1%
13. 13Nasopharyngitis195.1%
14. 14Rash184.9%
15. 15Anaemia174.6%

Recent PubMed references pinned to Acetic Acid as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Diphenylpiperazine attached to different triazole acetamide derivatives as a potent α-glucosidase inhibitor, new insight into the in silico study of an uncompetitive inhibitor.
  Journal of computer-aided molecular design · 2026 · Ghasemi M, Sepehri N, Biglar M, et al.
  PMID 42257774DOI 10.1007/s10822-026-00847-w
• New-onset erythrodermic psoriasis associated with antiepileptic drug use.
  Dermatology online journal · 2026 · Feng J, Shah P, Cloutier J, et al.
  PMID 42246351DOI 10.25251/5bv66v50
• Comparing the safety and efficacy of sodium valproate, levetiracetam, and phenytoin in attenuating the severity of agitation in patients with post-traumatic brain injury: An observational study.
  PloS one · 2026 · Singh S, Nayak R, Gangachannaiah S, et al.
  PMID 42234767DOI 10.1371/journal.pone.0350585
• Anti-asthma drug montelukast induces autistic behaviors via disrupting neuronal retinoic acid signaling.
  Signal transduction and targeted therapy · 2026 · Hao ZJ, Wu QH, Li YL, et al.
  PMID 42230569DOI 10.1038/s41392-026-02665-w
• Slow-inactivated sodium channels as a therapeutic target in trigeminal neuralgia: evidence from a systematic review and meta-analysis of lacosamide.
  Journal of oral & facial pain and headache · 2026 · Meechumnarn T, Phutinart S, Anukoolwittaya P, et al.
  PMID 42220289DOI 10.22514/jofph.2026.037
• In Situ pH Determination Using (1)H-MRS Acetate Chemical Shift for Noninvasive Postmortem Examinations.
  NMR in biomedicine · 2026 · Frese S, Gascho D, Thali MJ, et al.
  PMID 42219944DOI 10.1002/nbm.70323
• Valorization of bamboo vinegar through modified biochar for synergistic cadmium immobilization and phosphorus activation in saline alkaline soil.
  Bioresource technology · 2026 · Yang C, Xie Y, Wei L, et al.
  PMID 42219121DOI 10.1016/j.biortech.2026.135032
• Synergistic Effects of Acetic Acid and Ethanol on Offspring Production and Gallery Expansion by Fungus-Farming Ambrosia Beetles.
  Journal of chemical ecology · 2026 · Ranger CM, Baniszewski JA, Patwa N, et al.
  PMID 42216980DOI 10.1007/s10886-026-01725-3

The 10 most recently updated of 365 ClinicalTrials.gov registrations naming Acetic Acid as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia
  Active not recruiting · Phase 1 · Interventional · 24 enrolled · National Cancer Institute (NCI)
  NCT04190550updated 2026-06-11
• Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia
  Active not recruiting · Phase 1 · Interventional · 58 enrolled · National Cancer Institute (NCI)
  NCT03041688updated 2026-06-11
• Cytomegalovirus Infection in Patients With HIV-1 Infection
  Completed · Phase 3 · Interventional · 392 enrolled · University Hospital, Bordeaux
  NCT04067869updated 2026-06-10
• Acute Effect of Apple Cider Vinegar on Postprandial Plasma Malondialdehyde in Adult With Obesity
  Completed · Interventional · 46 enrolled · Indonesia University
  NCT07414875updated 2026-06-09
• Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women Living With HIV
  Not yet recruiting · Interventional · 17,734 enrolled · UNC Lineberger Comprehensive Cancer Center
  NCT07624123updated 2026-06-03
• Clinical Study of DTX301 AAV-Mediated Gene Transfer for Ornithine Transcarbamylase (OTC) Deficiency
  Active not recruiting · Phase 3 · Interventional · 37 enrolled · Ultragenyx Pharmaceutical Inc
  NCT05345171updated 2026-06-02
• Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV
  Recruiting · Interventional · 7,597 enrolled · UNC Lineberger Comprehensive Cancer Center
  NCT07428330updated 2026-05-28
• Effect of Diode Laser, Gudmar and Vinegar in Diabetic Patients During Root Canal Treatment
  Recruiting · Interventional · 90 enrolled · Sharda University
  NCT07549373updated 2026-05-28
• Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions
  Not yet recruiting · Interventional · 2,689 enrolled · Changhai Hospital
  NCT07601217updated 2026-05-22
• Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis
  Recruiting · Interventional · 120 enrolled · Konya Beyhekim Training and Research Hospital
  NCT07493226updated 2026-05-14

Frequently asked questions

What is Acetic Acid used for?

According to FDA labeling, Acetic Acid carries indications including: For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Acetic Acid?

Acetic Acid is classified as Antiinfectives, Organic acids.

What are the brand names for Acetic Acid?

Acetic Acid is marketed under brand names including Fem pH, Mal-A-Ket, Relagard.

What are the contraindications for Acetic Acid?

Acetic Acid labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.