Ear Pain MD Unit Dose by Eosera, Inc Ear Pain MD® Unit Dose

Drug Details [pdf]

EAR PAIN MD UNIT DOSE- lidocaine hydrochloride liquid
Eosera Inc

----------

Ear Pain MD® Unit Dose

DRUG FACTS

Active ingredient

Lidocaine HCL Monohydrate 4%

Purpose

Topical Analgesic

Use

for the temporary relief of pain.

Warnings

Keep out of reach of children.

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

Do not use

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

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.

Inactive ingredients

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

Questions?

Call 844-732-7929

(M-F 9:00am – 5:00pm CST)

PRINCIPAL DISPLAY PANEL - 10 Vial Carton

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

EAR PAIN MD UNIT DOSE
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72429-0003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0)
ACETIC ACID (UNII: Q40Q9N063P)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72429-0003-9	10 in 1 CARTON	06/10/2024
1		0.5 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M017	06/10/2024	05/30/2025

Labeler - Eosera Inc (079789050)

Name	Address	ID/FEI	Business Operations
Establishment
Eosera Inc		079789050	MANUFACTURE(72429-0003)

Revised: 8/2024

Document Id: ebb7d481-2404-4b77-8d19-d9b2a9e8804f

Set id: 10fef6ba-297f-4e5f-8769-d12ba94cdcba

Version: 2

Effective Time: 20240821

�