NDC 44577-704 Lidostat

Lidocaine Hcl

NDC Product Code 44577-704

NDC 44577-704-02

Package Description: 1 TUBE in 1 CARTON > 56 g in 1 TUBE

NDC Product Information

Lidostat with NDC 44577-704 is a a human over the counter drug product labeled by Clinical Therapeutic Solutions. The generic name of Lidostat is lidocaine hcl. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clinical Therapeutic Solutions

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Lidostat 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • LAURETH-7 (UNII: Z95S6G8201)
  • UREA (UNII: 8W8T17847W)

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.
  • 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: Clinical Therapeutic Solutions
Labeler Code: 44577
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 06-19-2013 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’.

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Lidostat Product Label Images

Lidostat 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 HCL 4%


External Anesthetic


For temporary relief of pain and itching caused by minor skin irritations.


For external use only.

Do Not Use

On children under 2 years of age unless directed by a physician.

When Using This Product

Avoid contact with eyes Use only as directed. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use And Ask A Doctor If:

  • Symptoms persist for more than seven days, or clear up and occur again within a few days.redness, irritation, swelling, pain or other symptoms increase

Keep Out Of Reach Of Children.

If swallowed, consult a physician.


For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.Children under 2 years of age: Ask a doctor.

Other Information:

Store at room temperature (68-77ºF) (20º-25ºC)

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bin Vinyl Dimethicone/Dimethicone Copolymer, C13-14 Isoparaffin, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Stearic Acid, Triethanolamine, Urea.

Lidostattm Cream

Distributed by:


A Part of bako's Integrated Physician Solution

PO Box 1257, Wall, NJ 07719

732.894.9450 •


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