Ear Pain MD (E007) by Eosera Inc Ear Pain MD (E007)

Ear Pain MD (E007) by

Drug Labeling and Warnings

Ear Pain MD (E007) by is a Otc medication manufactured, distributed, or labeled by Eosera Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EAR PAIN MD (E007)- ear pain md liquid 
Eosera Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ear Pain MD (E007)

Active ingredient

Lidocaine HCl Monohydrate 4%

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain

Warnings

For external use only, Do not ingest, Avoid contact with the eyes, 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, Do not use in large quantities, particularly over raw surfaces or blisterred areas, Do not use if you are allergic to any ingredient in this product, Do not use if you have an injury or perforation (hole) of the eardrum

Directions

Consult your doctor before use. Adults and children 2 years of age and older: Apply 2 to 3 drops to affected area not more than 3 to 4 times daily or as directed by your doctor.

Children under 2 years of age: Consult a doctor

Other information

store at room temperature

Inactive ingredients

Aloe Barbadensis (Aloe), Benzalkonium Chloride, Benzyl Alcohol, Glycerin, Propylene Glycol, Water

Keep out of reach of children

Principle Display

See image

EAR PAIN MD (E007) 
ear pain md liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72429-0072
Route of Administration	AURICULAR (OTIC)

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
BENZYL ALCOHOL (UNII: LKG8494WBH)	0.35 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	5 g  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.01 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.4 g  in 100 mL
WATER (UNII: 059QF0KO0R)	89.84 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.4 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72429-0072-2	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/15/2020	08/03/2020

Labeler - Eosera Inc (079789050)

Registrant - Eosera Inc (079789050)

Revised: 6/2021

Document Id: b2c35877-6625-4dba-99e0-0f68ca343edb

34390-5

Set id: a9dbedd5-a6fc-3a3f-e053-2a95a90a9085

Version: 2

Effective Time: 20210625

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