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Otovel: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
0.75 mg/0.25 mL, 0.0625 mg/0.25 mL
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Otovel

INSTRUCTIONS FOR USE

OTOVEL (OH-toe-vel)

(ciprofloxacin and fluocinolone acetonide)

otic solution

Read this Instructions for Use that comes with OTOVEL before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information about OTOVEL:

  • OTOVEL is for use in the ear only (otic use). Do not inject OTOVEL or use OTOVEL in the eye.
  • Use OTOVEL Solution exactly as your healthcare provider tells you to use it.

How should I use OTOVEL?

Step 1.You or your caregiver should wash their hands with soap and water.
Step 2.Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue. Do notput a cotton swab or any other object in the ear canal.
Step 3.Remove OTOVEL from the protective foil pouch. Pull apart 1 single-dose vial of OTOVEL as shown, by tearing along the dotted lines (perforations) until it is fully separated.
Step 4.Warm the dose of OTOVEL by holding the vial in your hand for 1 to 2 minutes.
Step 5.Twist off the vial cap in the direction of the arrow as shown.
Step 6.The person receiving OTOVEL should be on his/her side with the infected ear up as shown.
Step 7.Hold the vial of OTOVEL in your hand and place the vial close to the ear. Let the entire dose of OTOVEL fall into the affected ear.
Step 8.Gently press the part of the ear known as the tragus 4 timesusing a pumping motion as shown. This will allow the drops of OTOVEL to enter the middle ear.
Step 9.Remain on your side with the affected ear facing upward for 1 minute.
Step 10.If your healthcare provider has told you to use OTOVEL in both ears, repeat Steps 2-9 for the other ear.
Step 11.Safely throw away OTOVEL vials after use.

This Instructions for Use has been approved by the Food and Drug Administration.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 208251 · View the label on DailyMed

Revision date stated in the text: June 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Otovel

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Corticosteroid, Fluoroquinolone Antibacterial
Active ingredients Ciprofloxacin 0.75 mg/0.25 mL, Fluocinolone acetonide 0.0625 mg/0.25 mL
Dosage form Solution
Route Auricular (otic)
Marketing status not in the current FDA NDC Directory
Company (applicant) LAB SALVAT
FDA approval NDA 208251New Drug Application (NDA) Approved April 29, 2016
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
0.75 mg/0.25 mL, 0.0625 mg/0.25 mL – 0.25 ml in 1 vial, single-dose / 14 in 1 pouch / 1 in 1 carton NDC 66992-128-14

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.