NDC 63135-811 Lipocaine 5

Lidocaine 5%

NDC Product Code 63135-811

NDC Code: 63135-811

Proprietary Name: Lipocaine 5 Additional informationCallout TooltipWhat 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: Lidocaine 5% Additional informationCallout TooltipWhat 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.


Code Structure
  • 63135 - Esba Laboratories Inc.
    • 63135-811 - Lipocaine 5

NDC 63135-811-04

Package Description: 113 g in 1 TUBE

NDC 63135-811-30

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

NDC Product Information

Lipocaine 5 with NDC 63135-811 is a a human over the counter drug product labeled by Esba Laboratories Inc.. The generic name of Lipocaine 5 is lidocaine 5%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Esba Laboratories Inc.

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 Additional informationCallout TooltipWhat 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.


Lipocaine 5 Active Ingredient(s)

Additional informationCallout TooltipWhat 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 5 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SUCROSE DISTEARATE (UNII: 33X4X4B90S)
  • .BETA.-SITOSTEROL (UNII: S347WMO6M4)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • WATER (UNII: 059QF0KO0R)
  • ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • SUCROSE STEARATE (UNII: 274KW0O50M)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Esba Laboratories Inc.
Labeler Code: 63135
FDA Application Number: part346 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-18-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Lipocaine 5 Product Label Images

Lipocaine 5 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 5%

Purpose

Topical Anesthetic

Use

For temporary relief of pain and itching due to anorectal disorders.

Warnings

For external use only.

When Using This Product:

  • Avoid contact with eyesdo not use in large quantities, particularly over raw surfaces or blistered areasdo not put in rectumdo not exceed recommended dosage unless directed by a doctor.

Stop Use And Ask A Doctor If:

  • Allergic reaction occursrectal bleeding occurscondition worsens or does not improve within 7 dayssymptoms clear up and return within a few daysredness, irritation, swelling, pain or other symptoms begin or increase.

Keep Out Of The Reach Of Children:

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions:

  • When practical, clean area with mild soap and warm water and rinse thoroughly Gently dry by patting or blotting with toilet tissue or soft cloth before applying Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day Children under 12 years of age: consult a doctor.

Other Information:

  • Store at room temperature 20-25oC (68-77oF). Child-Resistant Cap: push down and turn to openAvailable in 1 Oz (30 g) and 4 Oz (113 g) tubes

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf Extract, Beta-Sitosterol, Caprylhydroxamic Acid, Cetyl Alcohol, Cetyl Palmitate, Glycerin, Glyceryl Caprylate, Isostearyl Alcohol, Lecithin, Purified Water, Sucrose Distearate, Sucrose Stearate , Tocopheryl Acetate, Triethylcitrate, Xanthan Gum.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am - 5 pm (EST) M - F or visit www.esbalabs.com

Label On Tube And Outer Carton

Lipocaine 5 tube 113 grams labelLipocaine 5 tube 30 grams labelOuter carton of Lipocaine 5 - 30 g tube

* Please review the disclaimer below.

Previous Code
63135-581
Next Code
63138-120