EAR ITCH MD- pramoxine hydrochloride spray

Ear Itch MD by

Drug Labeling and Warnings

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

Drug Details [pdf]

WARNINGS

Active Ingredient

Pramoxine HCl 1%

Purpose

Topical anethetic

Uses

For the temporary relief of itching associated with minor skin irritations

Warnings

• Keep out of reach of children
• 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 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

Principle Display

INGREDIENTS AND APPEARANCE

EAR ITCH MD 
pramoxine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72429-0071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	5 g  in 100 mL
Glycerin (UNII: PDC6A3C0OX)	0.4 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.4 g  in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	0.35 g  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.01 g  in 100 mL
water (UNII: 059QF0KO0R)	92.84 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72429-0071-5	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2019

Labeler - Eosera Inc (079789050)

Establishment
Name	Address	ID/FEI	Business Operations
Eosera Inc		079789050	manufacture(72429-0071)