EAR PAIN MD- lidocaine hydrochloride liquid EAR PAIN MD FOR KIDS- lidocaine hydrochloride liquid

Ear Pain MD for Kids by

Drug Labeling and Warnings

Ear Pain MD for Kids 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 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 or 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 and over: Apply 2 to 3 drops to affected area not more than 3 to 4 times daily.
• Children under 2 years: 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 - 12.5 mL Bottle Carton

EAR
PAIN MD®

Pain Relieving Drops

with 4% LIDOCAINE

0.42 fl oz (12.5 mL)

PRINCIPAL DISPLAY PANEL - 12.5 mL Bottle Carton - Kids

EAR
PAIN MD®

Pain Relieving Drops

with 4% LIDOCAINE

0.42 fl oz (12.5 mL)

INGREDIENTS AND APPEARANCE

EAR PAIN MD 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72429-0001
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Benzyl Alcohol (UNII: LKG8494WBH)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72429-0001-9	1 in 1 CARTON	01/24/2022
1		12.5 mL in 1 BOTTLE, DROPPER; 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	01/24/2022

EAR PAIN MD FOR KIDS 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72429-0002
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Benzyl Alcohol (UNII: LKG8494WBH)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72429-0002-9	1 in 1 CARTON	01/24/2022
1		12.5 mL in 1 BOTTLE, DROPPER; 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	01/24/2022

Labeler - Eosera, Inc (079789050)

Establishment
Name	Address	ID/FEI	Business Operations
Eosera, Inc		079789050	MANUFACTURE(72429-0001, 72429-0002)