LEADER EAR DROPS FOR SWIMMERS- leader ear drops for swimmers liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Available from:
Cardinal Health
Administration route:
AURICULAR (OTIC)
Prescription type:
OTC DRUG
Therapeutic indications:
Ear Drying Aid Dries water in the ears
Authorization status:
OTC monograph final
Authorization number:
70000-0478-1

LEADER EAR DROPS FOR SWIMMERS- leader ear drops for swimmers liquid

Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

LEADER Ear Drops for Swimmers

Isopropyl Alcohol 95% in 5% Anhydrous Glycerin

Ear Drying Aid

Dries water in the ears

Flammable: Keep away from fire or flame

Do not use in the eyes

Apply 4 to 5 drops in each affected ear

Store at room temperature

keep tightly closed

Glycerin

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)

LEADER EAR DROPS FOR SWIMMERS

leader ear drops for swimmers liquid

Cardinal Health

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 478

Route of Administration

AURICULAR (OTIC)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -

UNII:ND2M416 30 2)

ISOPROPYL

ALCOHOL

9 50 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:70 0 0 0 -0 478 -

30 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/24/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt344

0 4/24/20 19

Labeler -

Cardinal Health (097537435)

Registrant -

Humco Holding Group, Inc (825672884)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Humco Ho lding Gro up,

8 256 728 8 4

label(70 0 0 0 -0 478 ) , pack(70 0 0 0 -0 478 ) , manufacture(70 0 0 0 -0 478 ) ,

a na lysis(70 0 0 0 -0 478 )

Revised: 4/2019

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