FDA.reportPublic FDA data

Ear Itch MD - Itch Relief Spray

Manufacturer
Eosera Inc
Effective date
2021-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:56:59

Label at a glance#

ProductEar Itch MD
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of itching associated with minor skin irritations

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Topical anethetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

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

INFORMATION FOR PATIENTS SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis (Aloe), Benzalkonium chloride, Benzyl alcohol, Glycerin, Propylene glycol, water

Principle Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72429-007172429-0071-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
GlycerinPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d55bbc5d-7d00-421f-a79a-ee4ee58aa729d4ea80e7-3452-44dd-a1eb-f3805d91bdfa2021-06-25Exact identifier
spl set id: d4ea80e7-3452-44dd-a1eb-f3805d91bdfa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.