ProtexaUrea 42% CreamRx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

ProtexaUrea 42% CreamRx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Drug Labeling and Warnings

Drug Details

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NOT APPLICABLE- protexa cream 
Sterling-Knight Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Protexa
Urea 42% CreamRx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION:

Protexa Cream (42% Urea) is a keratolytic emollient which is gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 42% Urea, Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glycerin, Ceteary Alcohol, Polysorbate 60, Dimethicone, C12-15 Alkyl Benzoate, Glyceryl Stearate, PEG-100 Stearate, Propylene Glycol, Aloe Barbadensis Leaf Juice Powder, Phenoxyethanol, Ethylhexylglycerin, Xanthan Gum, Citric Acid. Urea Urea is a diamide of carbonic acid with the following chemical structure:

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CLINICAL PHARMACOLOGY:

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.
Pharmacokinetics: The mechanism of action of topically applied urea is not yet known.

INDICATIONS AND USAGE:

This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

CONTRAINDICATIONS:

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product

WARNINGS:

KEEP OUT OF REACH OF CHILDREN.
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
General:
This product 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 and consult a physician.

Information for Patients:

Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.

Pregnancy:

Category C.
Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers:

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

ADVERSE REACTIONS:

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
CALL YOUR DOCTOR ABOUT SIDE EFFECTS.
Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:

Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.

HOW SUPPLIED:

Protexa Cream (42% Urea) is available as follows: 45g container, NDC: 69336-810-45

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing and excessive heat. Keep bottle tightly closed.

Distributed By:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663

Item: 810                                           Rev. 09/19

Protexa Urea 42% Cream - Label

protexalabel

Protexa Urea 42% Cream - Carton

protexacarton

NOT APPLICABLE 
protexa cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 69336-810
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) Urea42 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALMOND OIL (UNII: 66YXD4DKO9)  
GLYCERIN (UNII: PDC6A3C0OX)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Dimethicone (UNII: 92RU3N3Y1O)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 Stearate (UNII: YD01N1999R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Aloe (UNII: V5VD430YW9)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Xanthan Gum (UNII: TTV12P4NEE)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69336-810-451 in 1 CARTON02/06/2020
145 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/06/2020
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)
Establishment
NameAddressID/FEIBusiness Operations
Sterling-Knight Pharmaceuticals, LLC079556942manufacture(69336-810) , label(69336-810)

Revised: 2/2020
 
Sterling-Knight Pharmaceuticals, LLC


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