NDC 47682-320 Green Guard Burn

Lidocaine Hcl

NDC Product Code 47682-320

NDC CODE: 47682-320

Proprietary Name: Green Guard Burn 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 Hcl 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 medication is used to prevent and relieve pain during certain medical procedures (such as inserting a tube into the urinary tract). It is also used to numb the lining of the mouth, throat, or nose before certain medical procedures (such as intubation). Lidocaine jelly is also used to relieve pain caused by swelling of the urinary tract (urethritis). It works by numbing certain areas of the body that are moist. Lidocaine belongs to a class of drugs known as local anesthetics.

NDC Code Structure

  • 47682 - Unifirst First Aid Corporation

NDC 47682-320-02

Package Description: .0591 L in 1 BOTTLE, SPRAY

NDC Product Information

Green Guard Burn with NDC 47682-320 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Green Guard Burn is lidocaine hcl. The product's dosage form is spray and is administered via topical form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Green Guard Burn 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 HYDROCHLORIDE 20 g/L

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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 06-01-2021 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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Green Guard Burn Product Label Images

Green Guard Burn 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredientLidocaine HCl 2.0%

Otc - Purpose

PurposeExternal analgesic

Indications & Usage

Usesfor the temporary relief of pain associated with minor burns

Warnings

WarningsFor external use only.

Otc - Do Not Use

Do not use in large quantities, particularly over raw or blisterd areas

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayscondition clears up and occurs again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsadults and children 2 years of age and older: apply to affected area not more than 3-4times dailychildren under 2 years: consult a doctor

Other Safety Information

  • Other informationstore at room temperatureyou may report a serious adverse reaction to this product to 1-800-869-6970

Inactive Ingredient

Inactive ingredientsdiazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, tea tree oil, trolamine, water

* Please review the disclaimer below.