NDC 70000-0490

LEADER Earwax Removal Kit

Carbamide Peroxide 6.50% Kit

LEADER Earwax Removal Kit is a Auricular (otic) Liquid in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Carbamide Peroxide.

Product ID70000-0490_883d65e1-78ac-be9d-e053-2a95a90aa591
NDC70000-0490
Product TypeHuman Otc Drug
Proprietary NameLEADER Earwax Removal Kit
Generic NameCarbamide Peroxide 6.50% Kit
Dosage FormLiquid
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2019-05-06
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart344
Labeler NameCardinal Health
Substance NameCARBAMIDE PEROXIDE
Active Ingredient Strength7 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70000-0490-1

1 BOTTLE, DROPPER in 1 CARTON (70000-0490-1) > 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date2019-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0490-1 [70000049001]

LEADER Earwax Removal Kit LIQUID
Marketing CategoryOTC monograph final
Application Numberpart344
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-06

NDC 70000-0490-2 [70000049002]

LEADER Earwax Removal Kit LIQUID
Marketing CategoryOTC monograph final
Application Numberpart344
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-06

Drug Details

Active Ingredients

IngredientStrength
CARBAMIDE PEROXIDE6.5 g/100mL

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