NDC 63736-339 Dermarest Eczema Medicated

Hydrocortisone

NDC Product Code 63736-339

NDC CODE: 63736-339

Proprietary Name: Dermarest Eczema Medicated 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: Hydrocortisone 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.

  • This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

NDC Code Structure

  • 63736 - Insight Pharmaceuticals Llc

NDC 63736-339-24

Package Description: 24 CARTON in 1 CASE > 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Dermarest Eczema Medicated with NDC 63736-339 is a a human over the counter drug product labeled by Insight Pharmaceuticals Llc. The generic name of Dermarest Eczema Medicated is hydrocortisone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Insight Pharmaceuticals Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc 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.

Dermarest Eczema Medicated 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.

  • HYDROCORTISONE 10 mg/mL

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SAFFLOWER (UNII: 4VBL71TY4Y)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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.

Product Labeler Information

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

Labeler Name: Insight Pharmaceuticals Llc
Labeler Code: 63736
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-20-2010 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’.

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Information for Patients

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone is available with or without a prescription. Low-strength preparations (0.5% or 1%) are used without a prescription for the temporary relief of (1) minor s...
[Read More]

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Dermarest Eczema Medicated Product Label Images

Dermarest Eczema Medicated 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

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch lotion

Uses

  • Temporary relief of itching associated withminor skin irritationsinflammationrashes due to eczemaOther uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Otc - Do Not Use

Do not use for the treatment of diaper rash

Otc - When Using

When using this product do not get into the eyes.

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few days

Otc - Ask Doctor

Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times dailychildren under 2 years of agedo not use, consult a doctor

Other Information

  • Shake wellstore at room temperature 15° - 25°C (59°- 77°F)Keep carton for full drug facts.

Inactive Ingredients

Purified water, propylene glycol, glycerin,
cetyl alcohol, glyceryl stearate, dimethicone, aleurites moluccana seed
oil, zinc PCA, panthenol, carthamus tinctorius (safflower) flower extract,
camellia sinensis leaf extract, rheum palmatum root/stalk extract,
cyclohexasiloxane, cyclopentasiloxane, xanthan gum, disodium edetate,
sodium hydroxide, diazolidinyl urea

Questions?

Call 1-800-344-7239 or visit our website at www.dermarest.com

Other

Distributed by:INSIGHT Pharmaceuticals, LLC. Langhorne, PA 19047-1749

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