Cutivate (Page 4 of 4)

OVERDOSAGE

Topically applied CUTIVATE® Lotion can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

CUTIVATE® Lotion may be used in adult and pediatric patients 1 year of age or older. The safety and efficacy of CUTIVATE® Lotion in pediatric patients below 1 year of age have not been established (see PRECAUTIONS: Pediatric Use).

Atopic Dermatitis: Apply a thin film of CUTIVATE® Lotion to the affected skin areas once daily. Rub in gently.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. The safety and efficacy of drug use for longer than 4 weeks have not been established.

CUTIVATE® Lotion should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

HOW SUPPLIED

CUTIVATE® Lotion is supplied in

60 mL bottle NDC 0462-0434-60
120 mL bottle NDC 0462-0434-04

Store between 15° and 30°C (59° and 86°F). Do not refrigerate.

Keep container tightly sealed.

Revised: 05/2011

PharmaDerm ®
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com

Patent No. 7300669

I8434

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 120 ML LABEL

PharmaDerm®

NDC 0462-0434-04

CUTIVATE ®

(fluticasone propionate)

Lotion, 0.05%

For Topical Use Only –

Not for ophthalmic, oral

or intravaginal use.

Rx only 120 mL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 120 ML LABEL
(click image for full-size original)
CUTIVATE
fluticasone propionate lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0462-0434
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fluticasone propionate (fluticasone) fluticasone propionate 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
Propylene Glycol
Ceteth-20
Isopropyl Myristate
Dimethicone 350
Cetostearyl Alcohol
Citric Acid Monohydrate
Trisodium Citrate Dihydrate
Imidurea
Methylparaben
Propylparaben
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0462-0434-60 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
1 60 mL in 1 BOTTLE This package is contained within the CARTON (0462-0434-60)
2 NDC:0462-0434-04 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
2 120 mL in 1 BOTTLE This package is contained within the CARTON (0462-0434-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021152 10/05/2009
Labeler — PharmaDerm, A division of Nycomed US Inc. (043838424)
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 043838424 ANALYSIS
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 174491316 MANUFACTURE

Revised: 05/2011 PharmaDerm, A division of Nycomed US Inc.

Page 4 of 4 1 2 3 4

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 © 2020. All Rights Reserved.