ear drops .065 mg/mL
Carbamide Peroxide 6.5% · LIQUID · Bionpharma Inc.
ear drops is a liquid containing carbamide peroxide 6.5% at .065 mg/mL, taken auricular (otic). Manufactured by Bionpharma Inc..
Key Facts
- Brand Name
- ear drops
- Generic Name
- Carbamide Peroxide 6.5%
- NDC Code (Product)
69452-377- Manufacturer
- Bionpharma Inc.
- Strength
- .065 mg/mL
- Dosage Form
- LIQUID
- Route
- AURICULAR (OTIC)
- Marketing Status
- Application #
- M014
- Marketing Start
- 09/15/2022
Recall History
Grato Holdings, Inc.
Microbial contamination of non-sterile product.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Lyne Laboratories, Inc.
Subpotent Drug
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.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Glenmark Pharmaceuticals Inc., USA
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Full Prescribing Information
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 69452-377, listed by Bionpharma Inc..
Other Carbamide Brands
See all →- EarWax Removal Kit Rite Aid11822-1222
- Ear Drops Major6.5 g/100mL0904-6627
- ERO Ear Wax Removal Kit6.5 g/100mL52412-175
- Ear Drops Major6.5 g/100mL50090-5273
- Earwax Removal Drops.065 mg/mL52412-600
- Walgreens Ear Wax Remover.065 mg/mL0363-2068
- Ear Drops.065 mg/mL69842-097
- Earwax Removal Drops.065 mg/mL82645-910
- EAR WAX RMVL Rite Aid6.5 g/100mL11822-1224
- Harris Teeter Earwax Removal Drops6.5 g/100mL69256-117
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)