Prescription Drug Information: Ketoconazole (Page 3 of 3)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — CARTON

45802-532-32

Rx Only

Ketoconazole Foam, 2%

For Topical Use Only.

Not For Ophthalmic, Oral, or Intravaginal Use.

100 g

carton
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The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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KETOCONAZOLE
ketoconazole aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-532
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
TERT-BUTYL ALCOHOL
ALCOHOL
BRUCINE SULFATE
POLYSORBATE 60
POTASSIUM CITRATE
PROPYLENE GLYCOL
WATER
STEARYL ALCOHOL
BUTANE
PROPANE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-532-32 1 CANISTER in 1 CARTON contains a CANISTER
1 50 g in 1 CANISTER This package is contained within the CARTON (45802-532-32)
2 NDC:45802-532-33 1 CANISTER in 1 CARTON contains a CANISTER
2 100 g in 1 CANISTER This package is contained within the CARTON (45802-532-33)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091550 08/30/2011
Labeler — Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 09/2022 Padagis Israel Pharmaceuticals Ltd

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