FDA.reportPublic FDA data

ear drops

Manufacturer
Bionpharma Inc. | Pharma Nobis, LLC
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:55:10

Label at a glance#

Productear drops
Active ingredientCARBAMIDE PEROXIDE
Label structure10 sections

Indications and uses

For occasional use as an aid to soften, loosen and remove excessive earwax

Dosage and administration

FOR USE IN THE EAR ONLY Remove any earing aids before use Adults and children over 12 yrs of age: tilt head to the side and place 10 drops into the ear. Tip of applicator should not enter into the ear canal Keep drops in ear for several minutes by keeping head tilted sideways or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

Purposes

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften, loosen and remove excessive earwax

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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 ear or after ear surgery, unless directed by a doctor
  • for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

  • you need to use for more than four days
  • excessive earwax remains after a four day treatment with this product

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY
Remove any earing aids before use

Adults and children over 12 yrs of age:tilt head to the side and place 10 drops into the ear.

  • Tip of applicator should not enter into the ear canal
  • Keep drops in ear for several minutes by keeping head tilted sideways or placing cotton in the ear.
  • Use twice daily for up to 4 days if needed, or as directed by a doctor.
  • Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.

Children under 12 yrs of age:Consult a physician.

Other information

SPL UNCLASSIFIED SECTION

  • do not store above 77°F (25°C)
  • store bottle in outer carton
  • product foams on contact with ear was due to the release of oxygen. There may be an associated “crackling” sound.
  • keep cap on bottle when not in use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water.

Questions & comments?

SPL UNCLASSIFIED SECTION

call toll free 1-888-235-2466

SPL UNCLASSIFIED SECTION

a+health™

ear drops
carbamide
peroxide 6.5%

earwax
removal aid

SEALED FOR YOUR

PROTECTION.

DO NOT USE IF

SHRINKBAND

ON BOTTLE IS

BROKEN OR MISSING

AT TIME OF

PURCHASE.

* Debrox ® is a registered trademark of Medtech Products, Inc. This product is not affiliated with, manufactured, distributed or endorsed by Medtech Products, Inc.
Inc., owner of the registered
trademark Debrox ® .

DISTRIBUTED BY:
Bionpharma Inc., Princeton, NJ 08540

L0001185

R1125

Carton labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*compare to the active ingredient
in Debrox® Earwax Removal Aid

twin pack

a+health™

ear drops
carbamide
peroxide 6.5%

earwax removal aid


safe, gentle, non-irritating
easily cleanses ear with
microfoam action

1 fl oz (30mL)
two bottles 0.5 fl oz (15 mL) each

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN4
702050carbamide peroxide 65 MG/ML Otic SolutionSCD4
702050carbamide peroxide 6.5 % Otic SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-377-75ear drops15 mL in 1 BOTTLE, DROPPERLIQUID154
69452-377-75ear drops1 in 1 CARTONLIQUID14
69452-377-95ear drops15 mL in 1 BOTTLE, DROPPERLIQUID154
69452-377-95ear drops2 in 1 CARTONLIQUID24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-37769452-377-95, 69452-377-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM STANNATENJ7C1V83KGIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ear dropsCARBAMIDE PEROXIDE 6.5%Bionpharma Inc.e8bcf92c-ad32-49d5-e053-2995a90ae0c62026-04-27WarningsExact identifier
ndc (package): 69452-377-95
ndc (package): 69452-377-75
ndc (product): 69452-377
ndc11 (package): 69452037775
ndc11 (package): 69452037795
spl id: 507543ad-0cd9-75be-e063-6394a90aee95
spl set id: e8bcf92c-ad32-49d5-e053-2995a90ae0c6

Reported adverse events (FAERS/openFDA)#

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