NDC 69336-810 Not Applicable

Protexa

NDC Product Code 69336-810

NDC CODE: 69336-810

Proprietary Name: Not Applicable What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Protexa What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Urea is used to treat dry/rough skin conditions (e.g., eczema, psoriasis, corns, callus) and some nail problems (e.g., ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.

NDC Code Structure

  • 69336 - Sterling-knight Pharmaceuticals, Llc

NDC 69336-810-45

Package Description: 1 CONTAINER in 1 CARTON > 45 g in 1 CONTAINER

NDC Product Information

Not Applicable with NDC 69336-810 is a a human prescription drug product labeled by Sterling-knight Pharmaceuticals, Llc. The generic name of Not Applicable is protexa. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sterling-knight Pharmaceuticals, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Not Applicable Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • UREA 42 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sterling-knight Pharmaceuticals, Llc
Labeler Code: 69336
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-18-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Not Applicable Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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:

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 69336-810-45KEEP 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, LLCRipley, MS 38663Item: 810                                           Rev. 09/19

* Please review the disclaimer below.