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WaxRx Ear Wax Removal Aid Drops

Approved
Approval ID

7e08cd86-7ae4-7d12-e053-2991aa0a4cba

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 1, 2025

Manufacturers
FDA

DOCTOR EASY MEDICAL PRODUCTS, LLC

DUNS: 848752523

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Carbamide Peroxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72724-001
Application NumberM014
Product Classification
M
Marketing Category
C200263
G
Generic Name
Carbamide Peroxide
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (7)

TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBAMIDE PEROXIDEActive
Quantity: 6.5 g in 100 mL
Code: 31PZ2VAU81
Classification: ACTIB

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WaxRx Ear Wax Removal Aid Drops - FDA Drug Approval Details