NDC 68599-1182 Hydrocortisone

Hydrocortisone Cream

NDC Product Code 68599-1182

NDC Product Information

Hydrocortisone with NDC 68599-1182 is a a human over the counter drug product labeled by Mckesson. The generic name of Hydrocortisone is hydrocortisone cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Mckesson

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 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.

  • HYDROCORTISONE 1 g/100g
  • HYDROCORTISONE 1 g/100g

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Mckesson
Labeler Code: 68599
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: 03-14-2019 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: 12-31-2020 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.

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

Other

Drug Facts

Otc - Active Ingredient

Hydrocortisone Cream 1%Active Ingredients (in each gram)Hydrocortisone USP 10 mg

Otc - Purpose

PurposeAntipruritic (Anti Itch)

Indications & Usage

Indications:
For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis scrapes

For the temporary relief of external genital, feminine and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Warnings

  • Warnings:For external use onlyAvoid contact with eyesDo not exceed the recommended daily dosage unless directed by a doctorDo no use for treatment of diaper rashIn case of bleeding, consult a doctor promptlyConsult a doctor:Before use if you have a vaginal discharge (for external feminine itching)For external itching, do not exceed the recommended daily dosage or if bleeding occursIf condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use of this productWhen using this product:Do not put this product into rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

  • Do Not Use:With 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 1-800-222-1222

Dosage & Administration

  • Directions:For adults and children 2 years of age and older: apply externally to affected area not more than 3 to 4 times daily.Children under 2 years of age: do not use, consult a doctorAdults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.Children under 12 years or age; for external anal itching, consult a doctor.

Other Safety Information

  • Other Information:Store at controlled room temperature 59* to 86*F (15* to 30*C)Avoid excessive heat and humidityTamper Evident. Do not use if packet is torn, cut or opened

Inactive Ingredient

Inactive Ingredients:
Benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate.

Otc - Questions

Questions? Call 1-800-777-4908

* Please review the disclaimer below.

Previous Code
68599-1182
Next Code
68599-1183