NDC 59898-800 Hydrocortisone

Anti-itch Cream

NDC Product Code 59898-800

NDC 59898-800-01

Package Description: 1728 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC 59898-800-02

Package Description: 144 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 59898-800-03

Package Description: 25 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 59898-800-32

Package Description: 28 g in 1 TUBE

NDC 59898-800-36

Package Description: .9 g in 1 PACKET

NDC Product Information

Hydrocortisone with NDC 59898-800 is a a human over the counter drug product labeled by Water-jel Technologies. The generic name of Hydrocortisone is anti-itch cream. The product's dosage form is ointment and is administered via topical form.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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 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.

Hydrocortisone 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.


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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

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: Water-jel Technologies
Labeler Code: 59898
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: 04-30-2010 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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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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Hydrocortisone Product Label Images

Hydrocortisone 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 acetate (equivalent to  Hydrocortisone 1%)

Purpose

Anti-itch cream

Uses

  • For the temporary relief of itching associated with minor skin irritations and rashesother uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

For the treatment of diaper rash. Consult a doctor

When Using This Product

  • Avoid contact with eyesdo not begin use of any other hydrocortisone product unless you've consulted a doctor

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist more than 7 dayscondition clears up and occurs again within a few days

Keep Out Of The 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 older: apply to affected area not  more than 3 to 4 times dailychildren under 2 years; do not use, consult a doctor

Other Information

  • Clean the affected areastore at room temperaturedo not use any opened or torn packetsyou may report a serious adverse reaction to this product to 800-275-3433

Inactive Ingredients

Cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

Questions ?

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