Debrox Swimmers Ear 95 mL/100mL

isopropyl alcohol · LIQUID · Medtech Products Inc.

No Recall History

Plain English

Debrox Swimmers Ear is a liquid containing isopropyl alcohol at 95 mL/100mL, taken auricular (otic). Manufactured by Medtech Products Inc..

Key Facts

Brand Name: Debrox Swimmers Ear
Generic Name: isopropyl alcohol
NDC Code (Product): 63029-323
Manufacturer: Medtech Products Inc.
Strength: 95 mL/100mL
Dosage Form: LIQUID
Route: AURICULAR (OTIC)
Marketing Status
Application #: M014
Marketing Start: 04/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

glossodynia1,632 reports

pemphigus1,613 reports

hand deformity1,604 reports

joint swelling1,590 reports

infusion related reaction1,588 reports

helicobacter infection1,582 reports

impaired healing1,581 reports

irritable bowel syndrome1,574 reports

systemic lupus erythematosus1,569 reports

pericarditis1,561 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use dries water in the ears and relieves water-clogged ears after swimming showering bathing washing the hair

Dosage & Administration

Directions unscrew cap from bottle remove foil safety seal from bottle affix applicator cap to bottle remove red applicator cap tip apply 4 to 5 drops in each affected ear

Warnings

W arnings Flammable: Keep away from fire or flame Do not use in the eyes Ask a doctor before use if you have ear drainage or discharge ear pain, irritation or rash in the ear dizziness recently had ear surgery Stop use and ask a doctor if irritation (too much burning) or pain occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is Debrox Swimmers Ear used for?

Debrox Swimmers Ear contains isopropyl alcohol. It is a liquid taken auricular (otic). Consult your doctor for specific uses.

Is Debrox Swimmers Ear a controlled substance?

Debrox Swimmers Ear is not classified as a controlled substance by the DEA.

What is the generic name for Debrox Swimmers Ear?

The generic name for Debrox Swimmers Ear is isopropyl alcohol. There are 12 other brand versions of isopropyl alcohol.

What is the NDC code for Debrox Swimmers Ear 95 mL/100mL?

The NDC (National Drug Code) for Debrox Swimmers Ear 95 mL/100mL is 63029-323, listed by Medtech Products Inc..

Product NDC

63029-323

Package NDC

63029-323-01

Other Isopropyl Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)