NDC 73033-001 Omeza Lavage

Lidocaine

NDC Product Code 73033-001

NDC Product Information

Omeza Lavage with NDC 73033-001 is a a human over the counter drug product labeled by Omeza Llc. The generic name of Omeza Lavage is lidocaine. The product's dosage form is oil and is administered via topical form.

Labeler Name: Omeza Llc

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

Product Type: Human Otc 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.

Omeza Lavage 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.

  • LIDOCAINE 8 mg/mL

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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • COD LIVER OIL (UNII: BBL281NWFG)
  • GLYCERYL LAURATE (UNII: Y98611C087)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • PALM OIL (UNII: 5QUO05548Z)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Omeza Llc
Labeler Code: 73033
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-15-2019 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.

Omeza Lavage Product Label Images

Omeza Lavage 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

Lidocaine 0.8%

Purpose

External analgesic

Use

For the temporary relief of pain

Warnings

For external use only

Do Not Use

  • In large quantities, particularly over raw surfaces or blistered areason puncture woundsdo not use if you are allergic to lidocaine or any of the inacitve ingredients listed below

When Using This Product

  • Use only as directed. Read and follow all directions and warnings on this carton.do not allow contact with the eyes

Stop Use And Ask A Doctor If

  • Allergic reaction occurscondition worsens or if symptoms persist for more than 7 dayssymptoms clear up and return within a few daysredness, irritation, swelling, pain or other symptoms begin or increase

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children

And pets. If swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • Adults and children 12 years and older: Apply a thin layer to affected area every 8 to 12 hours.Children under 12 years: Consult a physician before use.Instructions for useclean and dry affected areasnap open top of vialapply a thin layer to affected areadiscard vial with any excess or unused dosewash hands thoroughly after applying

Other Information

  • Do not use if package is damaged or open.protect from freezing or excessive heatstore at 68°-77°F (20°-25°C).

Inactive Ingredients

Caprylic Fatty Acid, Caprylic/Capric Triglyceride, Cetyl Esters NF, Cod Liver Oil, Glyceryl Monolaurate, Hempseed Oil, Palm Oil

Questions?

Call toll-free 888-886-6392 or visit www.omeza.com

* Please review the disclaimer below.

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