For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
Prescription medicine Auricular (otic) Safety alerts on record
How to use Dilute acetic acid
What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
Who it is for
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
How to take it and how often
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
Children
Safety and effectiveness
In pediatric patients below the age of 3 years have not been established
Talk to a doctor first if
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.
Possible side effects
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.
How to store it
STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Manufactured by: Saptalis Pharmaceuticals, LLC Hauppauge, NY 11788 Distributed by: TruPharma, LLC Tampa, FL 33609 Rev. 03/20-R1
If you miss a dose
Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.
From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2024-12-27.
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro PharmaceuticalsU.S. FDA Class III
7 Aug 2024 · Taro Pharmaceuticals U.S.A., Inc. · CompletedFailed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro PharmaceutU.S. FDA Class III
6 Nov 2023 · Taro Pharmaceuticals Inc. · TerminatedFailed 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.
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCsU.S. FDA Class II
26 Apr 2023 · Akorn, Inc. · OngoingCGMP Deviations: Firm went out of business and could no longer continue stability studies.
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsU.S. FDA Class II
26 Apr 2023 · Akorn, Inc. · OngoingCGMP Deviations: Firm went out of business and could no longer continue stability studies.
A recall usually affects certain batches only. Compare the lot number on your pack.
Check your pack of Dilute acetic acid
3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts
Questions about Dilute acetic acid
What is Dilute acetic acid used for?
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. (From the official U.S. FDA label.)
How do I take Dilute acetic acid?
Follow your prescription or the leaflet in your pack. The official label says: 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 …
Do I need a prescription for Dilute acetic acid?
Usually yes. Dilute acetic acid is a prescription medicine in most countries. Rules differ by country.
What brands contain Dilute acetic acid?
Dilute acetic acid is sold under names such as Acetic Acid. Brand names differ between countries.
How can I check that my Dilute acetic acid is genuine?
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.