LEADER EAR DROPS FOR SWIMMERS liquid

LEADER Ear Drops for Swimmers by

Drug Labeling and Warnings

LEADER Ear Drops for Swimmers by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba Leader, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Isopropyl Alcohol 95% in 5% Anhydrous Glycerin

PURPOSE

Ear Drying Aid

INDICATIONS & USAGE

Dries water in the ears

WARNINGS

Flammable: Keep away from fire or flame

Do not use in the eyes

DOSAGE & ADMINISTRATION

Apply 4 to 5 drops in each affected ear

WHEN USING

Store at room temperature

keep tightly closed

INACTIVE INGREDIENT

Glycerin

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. in case of accidental ingestion, seek professional assitance or contact a poison control center immediately. (1-800-222-1222)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER EAR DROPS FOR SWIMMERS 
leader ear drops for swimmers liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0478
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	950 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0478-1	30 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	04/24/2019

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	label(70000-0478) , pack(70000-0478) , manufacture(70000-0478) , analysis(70000-0478)