NDC 0904-7623 Hydrocortisone With Aloe Maximum Strength

Hydrocortisone

NDC Product Code 0904-7623

NDC 0904-7623-31

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Hydrocortisone With Aloe Maximum Strength with NDC 0904-7623 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Hydrocortisone With Aloe Maximum Strength is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Major Pharmaceuticals

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 With Aloe Maximum Strength 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

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SORBIC ACID (UNII: X045WJ989B)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • WHITE WAX (UNII: 7G1J5DA97F)

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: Major Pharmaceuticals
Labeler Code: 0904
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: 04-21-2009 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’.

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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 With Aloe Maximum Strength Product Label Images

Hydrocortisone With Aloe Maximum Strength 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, USP 1%

Purpose

Anti-itch

Uses

  • For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:eczema
  • Insect bites
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Soaps
  • Jewelry
  • Detergents
  • Cosmetics
  • Psoriasis
  • Seborrheic dermatitis
  • For external genital, feminine and anal itching
  • Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

  • For external feminine itching if you have a vaginal discharge. Consult a doctor.
  • For the treatment of diaper rash. Consult a doctor.

When Using This Product

  • Avoid contact with the eyesdo not begin the use of any other hydrocortisone product unless directed by a doctorfor external anal itching:do not use more than directed unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • Symptoms last for more than 7 days
  • The condition gets worse
  • Symptoms clear up and occur again in a few days
  • Rectal bleeding occurs, consult doctor promptly

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 doctorFor external anal itchingAdults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this productChildren under 12 years of age: consult a doctor

Other Information

  • Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing. Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

Aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

* Please review the disclaimer below.