Carbamide peroxide 6.5%

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: Carbamide peroxide 6.5%
Generic name: EARWAX REMOVAL KIT
Manufacturer: Allegiant Health
Product type: HUMAN OTC DRUG
SPL set ID: 54515e9d-2225-4875-a1cf-a24a823300dd
SPL ID: 4f1c9234-6bb1-4795-af84-731f628424db
Version: 2
Effective date: 2025-10-28
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:11:49

Harmonized routes table
Harmonized routes
AURICULAR (OTIC)

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		Carbamide peroxide 6.5%	openfda.brand_name
generic name		EARWAX REMOVAL KIT	openfda.generic_name
manufacturer name		Allegiant Health	openfda.manufacturer_name
ndc	package	69168-488-68	openfda.package_ndc
ndc	product	69168-488	openfda.product_ndc
ndc11	package	69168048868	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
spl id		4f1c9234-6bb1-4795-af84-731f628424db	id
spl set id		54515e9d-2225-4875-a1cf-a24a823300dd	set_id
unii		31PZ2VAU81	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use 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) in the ear drum or after ear surgery, unless directed by a doctor for more than 4 days; if excessive earwax remains after use of this product, consult a doctor When using this product • avoid contact with eyes. If accidental contact with eyes occurs, flush eyes with water and consult a doctor Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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