FDA.reportPublic FDA data

CLEARCANAL EAR WAX SOFTERNER DROPS

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
CLEARCANAL EAR WAX SOFTERNER DROPS
Generic name
CARBAMIDE PEROXIDE
Manufacturer
A-S Medication Solutions
Product type
HUMAN OTC DRUG
SPL set ID
ac3d57a4-08d5-45f1-be84-f68eef9d1398
SPL ID
8e1768f1-f087-4fed-a34e-9887adeb45b2
Version
2
Effective date
2024-11-04
Source export date
2026-11-06
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:24:09
Harmonized routes table
Harmonized routes
AURICULAR (OTIC)

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: Do not use: If you have had an allergic reaction to carbamide peroxide. If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor For more than four consecutive days When using this product: void contact with the eyes Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.