NDC 55379-406 Cortisil Mdx

NDC Product Code 55379-406

NDC 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.

NDC Product Information

Cortisil Mdx with NDC 55379-406 is a product labeled by Biozone Laboratories,inc.. The generic name of Cortisil Mdx is . The product's dosage form is and is administered via form.

Labeler Name: Biozone Laboratories,inc.

Dosage Form: -

Product Type: 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.

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.

  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Labeler Information

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

Labeler Name: Biozone Laboratories,inc.
Labeler Code: 55379
Start Marketing Date: 03-25-2013 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: 12-31-2018 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: I 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...
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Cortisil Mdx Product Label Images

Cortisil Mdx 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

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 worsenssymptoms 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

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