NDC 65923-778 Shopko Hemorrhoidal

NDC Product Code 65923-778

NDC 65923-778-57

Package Description: 1 TUBE in 1 CARTON > 57 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 Hemorrhoidal with NDC 65923-778 is a product labeled by United Exchange Corp. The generic name of Shopko Hemorrhoidal is . The product's dosage form is and is administered via form.

Labeler Name: United Exchange Corp

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • LANOLIN (UNII: 7EV65EAW6H)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • THYME OIL (UNII: 2UK410MY6B)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • WHITE WAX (UNII: 7G1J5DA97F)

Product Labeler Information

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

Labeler Name: United Exchange Corp
Labeler Code: 65923
Start Marketing Date: 06-30-2013 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: 12-31-2017 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’.

* Please review the disclaimer below.

Shopko Hemorrhoidal Product Label Images

Shopko Hemorrhoidal 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 ingredients                                                         PurposeMineral Oil 14%........................................................ProtectantPetrolatum 74.9%.....................................................ProtectantPhenylephrine HCl 0.25%...................................Vasoconstrictor

Otc - Purpose

  • Useshelps relieve the local itching and discomfort associated with hemorrhoidstemporarily shrinks hemorrhoidal tissue and relieves burningtemporarily provides a coating for relief of anorectal discomfortstemporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

Warnings For external and/or intrarectal use only

Otc - Ask Doctor

  • Ask a doctor before use if you have heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are now taking a prescription drug for high blood pressure or depression

Otc - When Using

When using this product do not use more than the recommended daily dosage

Otc - Stop Use

  • Stop use and ask a doctor if bleeding occurscondition gets worse or does not get better within 7 daysintroduction of the applicator into the rectum causes additional pain

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a physician before use.

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.

Indications & Usage

  • Directionschildren under 12 years of age: ask a doctoradults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipegently dry by patting or blotting with a tissue or a soft cloth before applyingwhen first opening tube, remove foil sealfor intrarectal use: remove protective cover from applicator and attach to tubelubricate applicator well, then gently insert applicator into the rectumthoroughly clean applicator and replace protective cover after each useapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementalso apply ointment to external area

Storage And Handling

Other information store at 20° to 25°C (68° to 77°F)

Inactive Ingredient

Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

Dosage & Administration

Distributed ByUnited Exchange Corp17211 Valley View AveCerritos, CA 90703Made in Korea

* Please review the disclaimer below.