ELIDEL (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 100 g Carton

NDC 0187-5102-03

ELIDEL®
(pimecrolimus)cream 1%

Net Wt. 100 g

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.

If ELIDEL Cream gets in your eyes,
rinse your eyes with cold water.

ATTENTION PHARMACIST:
Each patient is required to receive the enclosed Medication Guide.

Rx only

carton100g
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 g Carton

NDC 0187-5101-02

ELIDEL®
(pimecrolimus)cream 1%

Net Wt. 60 g

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.

If ELIDEL Cream gets in your eyes,
rinse your eyes with cold water.

ATTENTION PHARMACIST:
Each patient is required to receive the enclosed Medication Guide.

Rx only

carton60g
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 g Carton

NDC 0187-5100-01

ELIDEL®
(pimecrolimus)cream 1%

Net Wt. 30 g

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.

If ELIDEL Cream gets in your eyes,
rinse your eyes with cold water.

ATTENTION PHARMACIST:
Each patient is required to receive the enclosed Medication Guide.

Rx only

carton30g
(click image for full-size original)

Package/Label Display Panel

IMAGE NOT AVAILABLE

imagenoneimagenone
ELIDEL pimecrolimus cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pimecrolimus (Pimecrolimus) Pimecrolimus 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
OLEYL ALCOHOL
PROPYLENE GLYCOL
SODIUM CETOSTEARYL SULFATE
SODIUM HYDROXIDE
STEARYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5102-03 1 TUBE in 1 CARTON contains a TUBE
1 100 g in 1 TUBE This package is contained within the CARTON (0187-5102-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021302 12/02/2001
ELIDEL pimecrolimus cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pimecrolimus (Pimecrolimus) Pimecrolimus 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
OLEYL ALCOHOL
PROPYLENE GLYCOL
SODIUM CETOSTEARYL SULFATE
SODIUM HYDROXIDE
STEARYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5101-02 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (0187-5101-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021302 12/02/2001
ELIDEL pimecrolimus cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pimecrolimus (Pimecrolimus) Pimecrolimus 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
OLEYL ALCOHOL
PROPYLENE GLYCOL
SODIUM CETOSTEARYL SULFATE
SODIUM HYDROXIDE
STEARYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5100-01 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (0187-5100-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021302 12/02/2001
ELIDEL pimecrolimus cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pimecrolimus (Pimecrolimus) Pimecrolimus 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
OLEYL ALCOHOL
PROPYLENE GLYCOL
SODIUM CETOSTEARYL SULFATE
SODIUM HYDROXIDE
STEARYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5103-04 1 TUBE in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (0187-5103-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021302 12/02/2001
Labeler — Bausch Health US, LLC (831922468)
Establishment
Name Address ID/FEI Operations
Novartis Pharma GmbH 333288046 MANUFACTURE (0187-5103), MANUFACTURE (0187-5102), MANUFACTURE (0187-5101), MANUFACTURE (0187-5100)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies Inc. 245141858 MANUFACTURE (0187-5103), MANUFACTURE (0187-5102), MANUFACTURE (0187-5101), MANUFACTURE (0187-5100), PACK (0187-5102), PACK (0187-5101), PACK (0187-5100), PACK (0187-5103), LABEL (0187-5102), LABEL (0187-5101), LABEL (0187-5100), LABEL (0187-5103)

Revised: 09/2020 Bausch Health US, LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.