NDC 47682-326 Green Guard Derma-caine Burn

Benzalkonium Chloride, Lidocaine

NDC Product Code 47682-326

NDC 47682-326-73

Package Description: 25 PACKET in 1 BOX > .9 g in 1 PACKET

NDC 47682-326-99

Package Description: .9 g in 1 PACKET

NDC Product Information

Green Guard Derma-caine Burn with NDC 47682-326 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Green Guard Derma-caine Burn is benzalkonium chloride, lidocaine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Unifirst First Aid Corporation

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.

Green Guard Derma-caine 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 5 mg/g
  • BENZALKONIUM CHLORIDE 1.3 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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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".

* Please review the disclaimer below.

Green Guard Derma-caine Burn Product Label Images

Green Guard Derma-caine 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 ingredientsBenzalkonium chloride 0.13%Lidocaine HCl 0.5%

Otc - Purpose

PurposesFirst aid antisepticExternal analgesic

Indications & Usage

  • Usesfirst aid to help prevent infection and for the temporary relief of pain and itching associated withminor cutsscrapesburns

Warnings

WarningsFor external use only.

Otc - Do Not Use

  • Do not usein the eyes or apply over large areas of the bodylonger than 1 week unless directed by a doctorin large quantities, particularly over raw surfaces or blistered areas

Otc - Ask Doctor

Ask a doctor before use if you havedeep or puncture wounds, animal bites or serious burns

Otc - When Using

When using this product avoid contact with the 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 immediately.

Dosage & Administration

  • Directionsadults and children 2 years of age and older:clean the affected areaapply a small amount of this product on the area 1 to 3 times dailymay be covered with a sterile bandagechildren under 2 years of age: consult a doctor

Other Safety Information

  • Other informationstore at room temperaturetamper evident. Do not use if packet is opened or tornyou may report a serious adverse reaction to this product to 800-869-6870

Inactive Ingredient

Inactive ingredientsaloe barbadensis leaf juice, cetyl alcohol, diazolidinyl urea, disodiun EDTA, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG 100, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Otc - Questions

Questions or comments? 1-800-869-6970

* Please review the disclaimer below.