Ketodan (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 100 g Can Carton

NDC 43538-530-10

Rx Only

Ketodan®
Ketoconazole Foam, 2%

For Topical Use Only.
Not For Ophthalmic, Oral,
or Intravaginal Use.

Net wt. 100 g

MEDIMETRIKSPHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL -- 100 g Can Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC 43538-531-10

Rx Only

Ketodan®
Ketoconazole
Foam, 2%
KIT

For Topical Use Only.

Not For Ophthalmic, Oral
or Intravaginal Use.

CONTENTS:
1 — Ketodan® (Ketoconazole Foam, 2%) — Net wt. 3.53 oz. (100 g)
1 — Rehyla® Hair & Body Cleanser — Net wt. 16 oz. (454 g)

MEDIMETRIKSPHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
Rehyla Hair and Body Cleanser Cleansing (cold creams, cleansing lotions, liquids, and pads)
KETODAN ketoconazole aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-530
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketoconazole (ketoconazole) ketoconazole 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
cetyl alcohol
anhydrous citric acid
alcohol
tert-butyl alcohol
brucine sulfate
polysorbate 60
potassium citrate
propylene glycol
water
stearyl alcohol
butane
propane
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43538-530-10 1 CAN in 1 CARTON contains a CAN
1 100 g in 1 CAN This package is contained within the CARTON (43538-530-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091550 06/15/2012
KETODAN ketoconazole kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-531
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43538-531-10 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 CAN 100 g
Part 2 1 BOTTLE, PUMP 454 g
Part 1 of 2
KETODAN ketoconazole aerosol, foam
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketoconazole (ketoconazole) ketoconazole 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
cetyl alcohol
anhydrous citric acid
alcohol
tert-butyl alcohol
brucine sulfate
polysorbate 60
potassium citrate
propylene glycol
water
stearyl alcohol
butane
propane
Packaging
# Item Code Package Description Multilevel Packaging
1 100 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091550 06/15/2012
Part 2 of 2
REHYLA HAIR AND BODY CLEANSER inert cream
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
water
glyceryl stearate SE
glycerin
cocamidopropyl betaine
cetyl alcohol
PEG-7 glyceryl cocoate
dimethicone
cocamidopropyl hydroxysultaine
disodium lauryl sulfosuccinate
caprylyl glycol
cholesterol
decyl glucoside
propylene glycol
phenoxyethanol
edetate disodium
hexylene glycol
salicylic acid
chamaemelum nobile flower
hyaluronate sodium
mica
titanium dioxide
xanthan gum
Packaging
# Item Code Package Description Multilevel Packaging
1 454 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 06/15/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091550 06/15/2012
Labeler — Medimetriks Pharmaceuticals, Inc. (019903816)
Establishment
Name Address ID/FEI Operations
Perrigo, Inc. 600093611 MANUFACTURE (43538-530), PACK (43538-530), LABEL (43538-530), ANALYSIS (43538-530)

Revised: 06/2019 Medimetriks Pharmaceuticals, Inc.

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