Protopic (Page 6 of 6)

PRINCIPLE DISPLAY PANEL FOR PROTOPIC® (TACROLIMUS) OINTMENT 0.03%

NDC 50222-203-30

Rx only

Protopic® (tacrolimus) Ointment 0.03%

30 g

Attention: Dispense with enclosed Medication Guide

carton 0.03 30g
(click image for full-size original)

PRINCIPLE DISPLAY PANEL FOR PROTOPIC® (TACROLIMUS) OINTMENT 0.1%

NDC 50222-211-30

Rx only

Protopic® (tacrolimus) Ointment 0.1%

30 g

Attention: Dispense with enclosed Medication Guide

carton 0.1 30g
(click image for full-size original)
PROTOPIC
tacrolimus ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50222-203
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 0.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PARAFFIN
PROPYLENE CARBONATE
PETROLATUM
WHITE WAX
.ALPHA.-TOCOPHEROL, DL-
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50222-203-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (50222-203-30)
2 NDC:50222-203-60 1 TUBE in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (50222-203-60)
3 NDC:50222-203-10 1 TUBE in 1 CARTON contains a TUBE
3 100 g in 1 TUBE This package is contained within the CARTON (50222-203-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050777 12/08/2000
PROTOPIC
tacrolimus ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50222-211
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50222-211-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (50222-211-30)
2 NDC:50222-211-60 1 TUBE in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (50222-211-60)
3 NDC:50222-211-10 1 TUBE in 1 CARTON contains a TUBE
3 100 g in 1 TUBE This package is contained within the CARTON (50222-211-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050777 12/08/2000
Labeler — LEO Pharma Inc. (832692615)

Revised: 04/2019 LEO Pharma Inc.

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