Drugplain

Ear Drops .065 mg/mL

Carbamide Peroxide 6.5% · LIQUID · CVS Pharmacy

8 Recalls on Record
Plain English

Ear Drops is a liquid containing carbamide peroxide 6.5% at .065 mg/mL, taken auricular (otic). Manufactured by CVS Pharmacy.

Key Facts

Brand Name
Ear Drops
Generic Name
Carbamide Peroxide 6.5%
NDC Code (Product)
69842-097
Manufacturer
CVS Pharmacy
Strength
.065 mg/mL
Dosage Form
LIQUID
Route
AURICULAR (OTIC)
Marketing Status
Application #
M017
Marketing Start
06/04/2019

Recall History

8 Recalls on Record
Class II05/24/2022

Grato Holdings, Inc.

Microbial contamination of non-sterile product.

TerminatedVoluntary: Firm initiated
Class III01/31/2014

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

TerminatedVoluntary: Firm initiated
Class III01/31/2014

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

TerminatedVoluntary: Firm initiated
Class II05/21/2021

Hill Dermaceuticals, Inc.

Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

TerminatedVoluntary: Firm initiated
Class II04/13/2018

Lyne Laboratories, Inc.

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II02/12/2015

Health Innovations Pharmacy, Inc

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

TerminatedVoluntary: Firm initiated
Class III01/31/2014

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

TerminatedVoluntary: Firm initiated
Class II01/04/2024

Glenmark Pharmaceuticals Inc., USA

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

TerminatedVoluntary: Firm initiated

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

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

Dosage & Administration

Apply 4 to 5 drops in each affected ear.

Warnings

Flammable : Keep away from fire or flame. Do not use in eyes. Ask a doctor before use if you have ear drainage or discharge pain, irritation or rash in ear had ear surgery dizziness Stop us and ask a doctor if irritation (too much burning) or pain occurs

Frequently Asked Questions

What is Ear Drops used for?

Ear Drops contains Carbamide Peroxide 6.5%. It is a liquid taken auricular (otic). Consult your doctor for specific uses.

Is Ear Drops a controlled substance?

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

What is the generic name for Ear Drops?

The generic name for Ear Drops is Carbamide Peroxide 6.5%. There are 11 other brand versions of Carbamide Peroxide 6.5%.

What is the NDC code for Ear Drops .065 mg/mL?

The NDC (National Drug Code) for Ear Drops .065 mg/mL is 69842-097, listed by CVS Pharmacy.