Umecta PD

Name: Umecta PD

Umecta PD Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using urea topical and call your doctor at once if you have:

  • severe redness or irritation of treated skin.

Common side effects may include:

  • mild itching; or
  • mild burning or stinging.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Umecta PD Drug Class

Umecta PD is part of the drug classes:

  • Carbamide products

  • Solutions producing osmotic diuresis

What do I need to tell my doctor BEFORE I take Umecta PD?

  • If you have an allergy to urea or any other part of Umecta PD (urea emulsion, lotion, and suspension).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Precautions

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

How Supplied


Umecta PD™ (urea, 40% - sodium hyaluronate 0.3%) bioadhesive emulsion is available in a:7 oz. bottle NDC 68712-017-02

Store at controlled room temperature 15-30°C (59-86°F).

Manufactured for:

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






Umecta PD  UREA
urea emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68712-017
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 400 mg  in 1 g
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
1 NDC:68712-017-01 3 g in 1 PACKET
2 NDC:68712-017-02 198.5 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2007
Labeler - Innocutis Holdings LLC (071501252)
Establishment
Name Address ID/FEI Operations
Sonar Products 104283945 manufacture
Revised: 12/2011   Innocutis Holdings LLC
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