NDC 0295-5030 Trimo-san

Oxyquinoline Sulfate And Sodium Lauryl Sulfate

NDC Product Code 0295-5030

NDC 0295-5030-18

Package Description: 113.4 g in 1 TUBE

NDC Product Information

Trimo-san with NDC 0295-5030 is a a human prescription drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Trimo-san is oxyquinoline sulfate and sodium lauryl sulfate. The product's dosage form is jelly and is administered via vaginal form.

Labeler Name: Denison Pharmaceuticals, Llc

Dosage Form: Jelly - A class of gels, which are semisolid systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water.

Product Type: Human Prescription Drug 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.

Trimo-san Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OXYQUINOLINE SULFATE .25 mg/g
  • SODIUM LAURYL SULFATE .1 mg/g

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • CARBOMER 934 (UNII: Z135WT9208)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Vaginal - Administration into the vagina.

Product Labeler Information

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

Labeler Name: Denison Pharmaceuticals, Llc
Labeler Code: 0295
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-16-2019 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: 12-31-2020 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: N 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.

Trimo-san Product Label Images

Trimo-san 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

Contents

Hydroxyquinoline Sulfate 0.025%; Sodium Lauryl Sulfate N.F. 0.01%. Adjusted with Triethanolamine to pH 4 in water dispersible base composed of Glycerine, Carbomer N.F., Citric Acid, Sodium Citrate U.S.P., Methylparaben N.F., Perfume and Antifoam Emulsion N.F.

Storage:

AFTER EACH USE Wipe threads of tube and the inside of the cap. RE-CAP TIGHTLY. Store at room temperature.

Trimo-San And Pregnancy

  • TRIMO-SAN has
  • NOT been tested for use during pregnancy.
  • CooperSurgical does not recommend the use of
  • TRIMO-SAN during pregnancy.
  • If you wish to become pregnant, do not use
  • TRIMO-SAN or any other personal hygiene product vaginally (douches, vaginal sprays, jellies or suppositories), for 6 hours prior to or following intercourse. Any product used within this time period could interfere with conception.

General Information

Use Cap to pierce seal in head of tubeInstructions for use inside packageKeep this product out of the reach of children

* Please review the disclaimer below.