MedPath
FDA Product

Ivermectin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Ivermectin

0591-4052

Regulatory Information

0591-4052

ANDA210019

C73584

November 30, 2022

USA

These highlights do not include all the information needed to use IVERMECTIN CREAM safely and effectively. See full prescribing information for IVERMECTIN CREAM. IVERMECTIN cream, 1%, for topical use Initial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

119723554

Active Ingredients

IVERMECTIN

Quantity: 10 mg in 1 g

Code: 8883YP2R6D

Class Code: ACTIB

DIISOPROPYL ADIPATE

Code: P7E6YFV72X

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

CARBOMER HOMOPOLYMER TYPE C

Code: 4Q93RCW27E

Class Code: IACT

HEXYLENE GLYCOL

Code: KEH0A3F75J

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

OLEYL ALCOHOL

Code: 172F2WN8DV

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

SORBITAN TRISTEARATE

Code: 6LUM696811

Class Code: IACT

Active Moieties

IVERMECTIN

Code: 8883YP2R6D

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