NDC 55628-9109 Theraseptin
NDC Product Code 55628-9109
Proprietary Name: Theraseptin 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
- 55628 - Cal Pharma
- 55628-9109 - Theraseptin
NDC 55628-9109-4
Package Description: 120 mL in 1 TUBE
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.
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
- Otc - Purpose
- Indications & Usage
- Warnings
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Dosage & Administration
- Inactive Ingredient
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.