EAR PAIN MD- pain relief drops solution/ drops

Ear Pain MD by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Lidocaine Hydrochloride - 4%

Purpose

Topical analgesic

Uses

For the temporary relief of pain

KEEP OUT OF REACH OF CHILDREN

Warnings:

• For external use only
• Do not ingest
• Avoid contact with 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 blistered areas
• Do not use if you are allergic to any ingredient in this product

Directions

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

Children under 2 years of age: consult a doctor

Other Information

Store at room temperature (20-25o C, 68-77o F)

Inactive Ingredients

Water, Aloe barbadensis (Aloe), Glycerin, Propylene glycol, Benzalkonium chloride

Package label

INGREDIENTS AND APPEARANCE

EAR PAIN MD 
pain relief drops solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72429-0070
Route of Administration	Topical

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72429-0070-6	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2018

Labeler - Eosera Inc (079789050)

Registrant - Eosera Inc (079789050)

Establishment
Name	Address	ID/FEI	Business Operations
Eosera Inc		079789050	manufacture(72429-0070) , label(72429-0070)