NDC 69747-040 Greencaine Blast

Lidocaine

NDC Product Code 69747-040

NDC CODE: 69747-040

Proprietary Name: Greencaine Blast 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: Lidocaine 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

  • 69747 - Alma Laboratories, Inc.

NDC 69747-040-01

Package Description: 113 g in 1 TUBE

NDC Product Information

Greencaine Blast with NDC 69747-040 is a a human over the counter drug product labeled by Alma Laboratories, Inc.. The generic name of Greencaine Blast is lidocaine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Alma Laboratories, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Greencaine Blast 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 40 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.

  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL LAURATE (UNII: Y98611C087)
  • JOJOBA OIL (UNII: 724GKU717M)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • 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.

  • 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: Alma Laboratories, Inc.
Labeler Code: 69747
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: 01-18-2018 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Greencaine Blast Product Label Images

Greencaine Blast 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

Drug Facts

Lidocaine 4%

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain and itching associated with minor skin irritations, minor cuts, minor burns, scrapes or insect bites.

Warnings

For external use only

Flammable

Keep away from heat, sparks, electrical, fire or flame.

When Using This Product

Avoid contact with the eyes.  Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use And Ask A Doctor

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product.

Keep Out Of The Reach Of Children

If swallowed, get medical helo or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected  area not more than 3 to times daily. Children under 2 years of age consult a doctor.

Inactive Ingredients:

Aloe barbadensis leaf juice (aloe vera), caprylyl glycol, carbomer, disodium EDTA, glycerin, glyceryl laurate, jojoba oil, SD alcohol 40-B, trithanolamine, water.

Questions:

Call


(888) 306-6933 or visit


www.greencaine.com

* Please review the disclaimer below.