EAR PAIN MD UNIT DOSE- lidocaine hydrochloride liquid

Ear Pain MD Unit Dose by

Drug Labeling and Warnings

Ear Pain MD Unit Dose by is a Otc medication manufactured, distributed, or labeled by Eosera, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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]

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	06/10/2024

Labeler - Eosera, Inc (079789050)

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