Ketoconazole (Page 2 of 2)

Principal Display Panel

Ketoconozole 2%
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Principal Display Panel

Ketoconozole 2%
(click image for full-size original)

Principal Display Panel

Ketoconozole 2%
(click image for full-size original)

KETOCONAZOLE
ketoconazole cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-554(NDC:51672-1298)
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
Butylated Hydroxyanisole
cetyl alcohol
isopropyl myristate
polysorbate 60
polysorbate 80
propylene glycol
water
sorbitan monostearate
stearyl alcohol
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-554-15 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (21695-554-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075638 12/18/2002
KETOCONAZOLE
ketoconazole cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-555(NDC:51672-1298)
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
Butylated Hydroxyanisole
cetyl alcohol
isopropyl myristate
polysorbate 60
polysorbate 80
propylene glycol
water
sorbitan monostearate
stearyl alcohol
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-555-30 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (21695-555-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075638 12/18/2002
KETOCONAZOLE
ketoconazole cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-556(NDC:51672-1298)
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
Butylated Hydroxyanisole
cetyl alcohol
isopropyl myristate
polysorbate 60
polysorbate 80
propylene glycol
water
sorbitan monostearate
stearyl alcohol
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-556-60 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (21695-556-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075638 12/18/2002
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 01/2011 Rebel Distributors Corp

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