Wax Out Plus

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: Wax Out Plus
Generic name: CARBAMIDE PEROXIDE DROPS
Manufacturer: NEILMED PHARMACEUTICALS INC
Product type: HUMAN OTC DRUG
SPL set ID: cf64f4b8-279c-8c1d-e053-2995a90ac853
SPL ID: 0eb0da5e-0fa4-b442-e063-6394a90a08f4
Version: 2
Effective date: 2024-01-11
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:52:47

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		Wax Out Plus	openfda.brand_name
generic name		CARBAMIDE PEROXIDE DROPS	openfda.generic_name
manufacturer name		NEILMED PHARMACEUTICALS INC	openfda.manufacturer_name
ndc	package	13709-313-01	openfda.package_ndc
ndc	product	13709-313	openfda.product_ndc
ndc11	package	13709031301	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
spl id		0eb0da5e-0fa4-b442-e063-6394a90a08f4	id
spl set id		cf64f4b8-279c-8c1d-e053-2995a90ac853	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 had an allergic reactionto carbamide peroxide or other ingredients in teh dropper bottle. If you have ear drainage or discharge, ear pain, ear infections, irritation, rash in the ear, or are dizzy. (Please consult a doctor with concerns). If you have an injury or perforation (hole) of the eardrum or after ear surgery or mastoid surgery, unless directed by a doctor. More than a twice a week. For children under 12 years of age. If you have tubes in your ears.

Reported adverse events (FAERS/openFDA)#

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