NDC 63174-224 Hydrocortisone

NDC Product Code 63174-224

NDC 63174-224-01

Package Description: 72 TUBE in 1 CASE > 28.3 g in 1 TUBE

NDC 63174-224-08

Package Description: 12 JAR in 1 CASE > 425 g in 1 JAR

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

NDC Product Information

Hydrocortisone with NDC 63174-224 is a product labeled by Choice Laboratories. The generic name of Hydrocortisone is . The product's dosage form is and is administered via form.

Labeler Name: Choice Laboratories

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Choice Laboratories
Labeler Code: 63174
Start Marketing Date: 02-02-2010 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: 12-31-2017 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...
[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

Otc - Active Ingredient

Active Ingredient                            PurposeHydrocortisone Acetate 1%            Antipruritic (anti-itch)

Uses:

  • For temporary relief of;minor skin irritationsItching and rashes due to; eczemainsect bitespoison ivypoison oakpoison sumacsoapsdetergentscosmeticsjewelryand for external itching of; genitalfeminine andanal itching

Warnings:

For external use only

Do Not Use:

  • In the eyeslonger than 1 week unless directed by a physicianfor diaper rashif you have vaginal dischargemore than the recommended daily dosage unless directed by a doctorin the rectum bu using fingers or any other mechanical device or applicator

Stop Use And Ask A Physician If:

  • The condition persists or gets worsesymptoms clear up and occur again within a few daysyou are pregnant or breast feeding

Keep Out Of Reach Of Children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Adults and children over 2 years of ageApply evenly to affected area no more than 3 or 4 times daily.Children under 2 years of ageDo not useconsult a physicianAdultsWhen practical, cleanse the affected area with mild soap and warm water and rinse thoroughlyGently dry, patting and blotting with bathroom tissue or soft cloth before applyingapply externally to the area up to 6 times daily or after each bowel movement

Other Information:

  • Store at 20 deg - 25 deg C (68 deg - 77 deg F)Avoid excessive heat and humidity

Inactive Ingredients:

Citric acid, Glycerin, Glycerol sterate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium citrate, Titanium dioxide, Water (purified)

* Please review the disclaimer below.