NDC 70648-009 Olp Hemorrhoidal Cooling

NDC Product Code 70648-009

NDC CODE: 70648-009

Proprietary Name: Olp Hemorrhoidal Cooling 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.

NDC Code Structure

  • 70648 - Ohio Lab Pharma

NDC 70648-009-01

Package Description: 1 TUBE in 1 CARTON > 20 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

Olp Hemorrhoidal Cooling with NDC 70648-009 is a product labeled by Ohio Lab Pharma. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 249465.

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)

Product Labeler Information

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

Labeler Name: Ohio Lab Pharma
Labeler Code: 70648
Start Marketing Date: 02-01-2017 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 - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Olp Hemorrhoidal Cooling Product Label Images

Olp Hemorrhoidal Cooling 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

Active Ingredient

Phenylephrine HCI, 0.25%

Purpose

  • VasoconstrictorAstringent

Uses

  • Helps relieve the local itching and discomfort associated with hemorrhoidstemporary relief of irritation and burningtemporarily shrinks hemorrhoidal tissueaids in protecting irritated anorectal areas

Warnings

For external use only

Ask A Doctor Before Use If You Have

  • Heart diseasehigh blood pressurethyroid diseasediabetesdifficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

Presently taking a prescription drug for high blood pressure or depression

When Using This Product

  • Do not exceed the recommended daily dosage unless directed by a doctordo not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Using And Ask Your Doctor If

  • Bleeding occurscondition worsens or does not improve within 7 days

If Pregnent Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel.when first opening the tube, puncture foil seal with top end of capapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementchildren under 12 years of age: ask a doctor

Other Information

Store at 20-25°C (68-77°F)

Inactive Ingredients

Edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite

Questions

Ohiolabpharma.us

Package Label

COOLING RELIEF

OLP HEMORRHOIDAL COOLING GEL

* Please review the disclaimer below.