Ivermectin (Page 3 of 3)

Package Label — 45 g

45g_carton_image
(click image for full-size original)

NDC 66993-948-48

Prasco

Rx OnlyIvermectin cream, 1%

For Topical Use Only

Keep Out of Reach of Children

NET WT. 45 g

IVERMECTIN ivermectin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-948
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVERMECTIN (IVERMECTIN) IVERMECTIN 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
ISOPROPYL PALMITATE
METHYLPARABEN
OLEYL ALCOHOL
PHENOXYETHANOL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM HYDROXIDE
SORBITAN MONOSTEARATE
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-948-48 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (66993-948-48)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA206255 10/15/2019
Labeler — Prasco Laboratories (065969375)
Establishment
Name Address ID/FEI Operations
G Production, Inc. 251676961 manufacture (66993-948)
Establishment
Name Address ID/FEI Operations
Hill Dermaceuticals, Inc. 098366990 repack (66993-948)

Revised: 08/2019 Prasco Laboratories

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