NDC 37012-059 Shopko Hydrocortisone Maximum Strength

  1. Labeler Index
  2. Shopko Stores Operating Co., Llc
  3. NDC: 37012-059 Shopko Hydrocortisone Maximum Strength

NDC Product Code 37012-059

NDC CODE: 37012-059

Proprietary Name: Shopko Hydrocortisone Maximum Strength 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.
Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 37012 - Shopko Stores Operating Co., Llc

NDC 37012-059-02

Package Description: 1 TUBE in 1 CARTON > 28.4 g in 1 TUBE

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

NDC Product Information

Shopko Hydrocortisone Maximum Strength with NDC 37012-059 is a product labeled by Shopko Stores Operating Co., Llc. The generic name of Shopko Hydrocortisone Maximum Strength is . The product's dosage form is and is administered via form.

Labeler Name: Shopko Stores Operating Co., Llc

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.
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Labeler Information

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

Labeler Name: Shopko Stores Operating Co., Llc
Labeler Code: 37012
Start Marketing Date: 08-23-1995 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: 12-31-2019 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’.

* Please review the disclaimer below.

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]

* Please review the disclaimer below.

Shopko Hydrocortisone Maximum Strength Product Label Images

Shopko Hydrocortisone 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

Other

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:eczemapsoriasispoison ivy, oak, sumacinsect bitesdetergentsjewelrycosmeticssoapsseborrheic dermatitistemporarily relieves external anal and genital itchingother uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

  • In the genital area 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 eyesdo not use more than directed unless told to do so by a doctordo not put directly into the rectum by using fingers or any mechanical device or applicator

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, and do not begin use of any other hydrocortisone product unless you have asked a doctorrectal bleeding occurs

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.

Directions

  • For itching of skin irritation, inflammation, and rashes:adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: ask a doctorfor external anal and genital itching, adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applyingapply to affected area not more than 3 to 4 times dailychildren under 12 years of age: ask a doctor

Other Information

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tubestore at room temperaturesee carton or tube crimp for lot number and expiration date

Inactive Ingredients

Aloe powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, paraffin wax, propylparaben, purified water, sodium lauryl sulfate, stearyl alcohol

Questions?

Call 1-866-923-4914

* Please review the disclaimer below.