Ear Pain MD Unit Dose

Manufacturer
Eosera, Inc
Effective date
2024-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:56:03

Label at a glance#

ProductEar Pain MD Unit Dose
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older Apply 2 to 3 drops to the affected area not more than 3 to 4 times daily. For children under 2 DO NOT USE, consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL Monohydrate 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

SPL UNCLASSIFIED SECTION

  • For external use only.
  • If swallowed, immediately call Poison Control 800-222-1222
  • Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw skin surfaces or blistered areas.
  • if you are allergic to any ingredient in this product.
  • if you have an injury or perforation (hole) of the eardrum, including tubes in the ear.
  • If conditions worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and olderApply 2 to 3 drops to the affected area not more than 3 to 4 times daily.
For children under 2DO NOT USE, consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis (Aloe), Benzalkonium chloride, Benzyl alcohol, Hypromellose (HPMC), Water. May contain Hydrochloric acid and/or Sodium hydroxide to adjust pH.

Questions?

OTC - QUESTIONS SECTION

Call 844-732-7929

(M-F 9:00am – 5:00pm CST)

PRINCIPAL DISPLAY PANEL - 10 Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

eosera®
EAR
PAIN MD®

PAIN RELIEVING DROPS
#1
DOCTOR
RECOMMENDED*

With 4% LIDOCAINE

10
sigle use
vials

10 vials [0.5 mL each]

PRINCIPAL DISPLAY PANEL - 10 Vial Carton
PRINCIPAL DISPLAY PANEL - 10 Vial Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72429-0003EAR PAIN MD UNIT DOSE (LIDOCAINE HYDROCHLORIDE) LIQUID [EOSERA, INC]1Unmatched20240823_10fef6ba-297f-4e5f-8769-d12ba94cdcba.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72429-000372429-0003-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
ebb7d481-2404-4b77-8d19-d9b2a9e8804f10fef6ba-297f-4e5f-8769-d12ba94cdcba2024-08-21WarningsExact identifier
spl set id: 10fef6ba-297f-4e5f-8769-d12ba94cdcba

Reported adverse events (FAERS/openFDA)#

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