ProRinse Earwax Removal System

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
ProRinse Earwax Removal System
Generic name
CARBAMIDE PEROXIDE
Manufacturer
McKeon Products Inc
Product type
HUMAN OTC DRUG
SPL set ID
ca82db28-1ef7-41c6-a46b-7bfc7b09281c
SPL ID
4a636cb5-104c-7811-e063-6294a90afcb0
Version
1
Effective date
2026-02-09
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:29:19
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 For use in the ear only Ask a doctor or pharmacist before use if you have: ear drainage or discharge recently had ear surgery dizziness pain, irritation, or rash in the ear an ear infection had an injury or perforation (hole) of the eardrum Stop use and ask doctor if : you need to use for more than four days excessive earwax remains after use of this product When using this product , avoid contact with the eyes When using earplugs , do not insert deeply into ear canal. Remove very slowly with a twisting motion to gradually break the seal. Due to the excellent seal characteristics, rapid removal may damage eardrum Keep this and all drugs out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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