Umecta PD description, usages, side effects, indications, overdosage, supplying and lots more!

Umecta PD

Innocutis Holdings LLC

Umecta PD

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Description



Rx only
For topical use only
Not for ophthalmic use







Description

Clinical Pharmacology



Pharmacokinetics

The mechanism of action of topically applied urea is not yet known.

Indications and Uses

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.


Precautions


Pregnancy Category C

Nursing Mothers

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Umecta is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Side Effects

Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing
the medication.

Dosage and Administration

How Supplied









Manufactured for:

Innocutis Holdings LLC
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.innocutis.com
www.umecta.com






Umecta PD

Urea SUSPENSION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68712-018
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UREA 400 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
SHEA BUTTER
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
SOYBEAN OIL
SUNFLOWER OIL
HYPROMELLOSES
water
SODIUM CITRATE
STEARIC ACID
HYALURONATE SODIUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68712-018-01 3 in 1 PACKET
2 NDC:68712-018-02 255.1 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2007-06-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.