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: 72429-0070-8	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)