NDC 55628-9109 Theraseptin

NDC Product Code 55628-9109

NDC 55628-9109-4

Package Description: 120 mL in 1 TUBE

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

NDC Product Information

Theraseptin with NDC 55628-9109 is a product labeled by Cal Pharma. The generic name of Theraseptin is . The product's dosage form is and is administered via form.

Labeler Name: Cal Pharma

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.

  • CHLOROTHYMOL (UNII: LJ25TI0CVT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LANOLIN (UNII: 7EV65EAW6H)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PHENOL (UNII: 339NCG44TV)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • THYMOL (UNII: 3J50XA376E)

Product Labeler Information

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

Labeler Name: Cal Pharma
Labeler Code: 55628
Start Marketing Date: 11-29-2012 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.

Theraseptin Product Label Images

Theraseptin 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

METHYL SALICYLATE (28%)MENTHOL (10%)CAPSAICIN (0.25%)

Otc - Purpose

TOPICAL ANALGESIC

Indications & Usage

Uses: A moisture barrier that prevents & helps heal skin irritations from: urine, diarrhea, perspiration, stula, drainage, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

Warnings

WARNINGS: FOR EXTERNAL USE ONLYAvoid contact with eyes. In case of contact, flush thoroughly with warm waterNot for use on deep or puncture wounds.

Otc - Stop Use

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children: In case of accidental ingestion contact a physician or Poison Control Center right away.

Dosage & Administration

DIRECTIONS- APPLY ON CLEAN SKIN AND GENTLY RUB OVER AREA WITH PAIN. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED AND RUBBED ONTO SKIN.

Inactive Ingredient

Inactive Ingredients: Calamine, Chlorothymol, Glycerin, Lanolin, Methylparaben, Petrolatum, Phenol, Propylparaben, Sodium Bicarbonate, Thymol

* Please review the disclaimer below.