NDC 55379-406 Cortisil Mdx

Product Information

What is NDC 55379-406?

The NDC code 55379-406 is assigned by the FDA to the product Cortisil Mdx which is product labeled by Biozone Laboratories,inc.. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 55379-406-01 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code55379-406
Proprietary Name 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.
Cortisil Mdx
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Biozone Laboratories,inc.
Labeler Code55379
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-25-2013
Listing Expiration Date 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.
12-31-2018
Exclude Flag 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".
I
NDC Code Structure

Product Packages

NDC Code 55379-406-01

Package Description: 1 BOTTLE, PUMP in 1 CARTON / 30 g in 1 BOTTLE, PUMP

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Cortisil Mdx Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Cortisil Mdx Inactive Ingredients UNII Codes

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.

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Patient Education

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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Cortisil Mdx Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Otc - Active Ingredient



Active ingredient
Hydrocortisone Acetate 1.0%
Purpose
Anti-Pruritic

Use



For the temporary relief of itching associated with minor skin irritations, inflammation and rashes.


Warnings



For external use only


Do Not Use



  • hydrocortisone product unless you have consulted a doctor.
  • on children under 2 years of age.
  • on mucous membranes

When Using This Product



  • avoid contact with the eyes.
  • If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center immediately.


Directions



Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 year of age: consult a doctor.


Other Information



Store at 15° to 30° C (59° to 86°F)

Carton: 1oz applicator pump


Inactive Ingredients



Cyclopentasiloxane, Dimethicone Crosspolymer, Cyclomethicone, PEG-12 Glyceryl Dimyristate, Disodium EDTA.


Questions?



call 1-760-734-3622


Package Label.Principal Display Panel



NET WT. 30G          NDC 55379-406-01

CortiSILTMMDX
HYDROCORTISONE ACETATE 1% GEL

CONTAINS:
HYDROCORTISONE ACETATE 1% GEL
IN A NON-AQUEOUS SILICONE
AND SILICONE-CROSS POLYMER BASE.

FOR EXTERNAL USE ONLY

Store: Room Temperature

US Patents: Pending

MOKO
THERAPEUTICS LLC

Distributed By:
Moko Therapeutics LLC
Carlsbad, CA 92011


* Please review the disclaimer below.