NDC 73408-260 Crane Safety Burn

Lidocaine

NDC Product Code 73408-260

NDC 73408-260-12

Package Description: 10 PACKET in 1 BOX > .9 g in 1 PACKET

NDC 73408-260-73

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

NDC Product Information

Crane Safety Burn with NDC 73408-260 is a a human over the counter drug product labeled by Crane Safety Llc. The generic name of Crane Safety Burn is lidocaine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Crane Safety Llc

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.

Crane Safety 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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALCOHOL (UNII: 3K9958V90M)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WHITE WAX (UNII: 7G1J5DA97F)

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: Crane Safety Llc
Labeler Code: 73408
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: 01-17-2020 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’.

* Please review the disclaimer below.

Crane Safety Burn Product Label Images

Crane Safety 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

Active Ingredients

Benzalkonium chloride 0.13%Lidocaine HCl 0.5%

Purpose

Topical antisepticTopical analgesic

Uses

  • First aid to help prevent infection in minor cuts, scrapes and burns.For temporary relief of pain and itching associated with:sunburnminor burnsinsect bitesminor skin irritationcutsscrapes

Warnings

For external use only.

Do Not Use

  • In the eyesover large areas of the body or on deep puncture wounds, animal bites or serious burnsin large quantities, particularly over raw surfaces or blistered areas

Stop Use And Ask A Doctor If

  • Condition gets worsecondition clears up and recurs within a few dayscondition persists for more than 7 days

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 12 years and over:clean the affected areaapply a small amount of this product on the area 3 to 4 times dailymay be covered with a sterile bandageChildren under 12 years:consult a doctor

Other Information

  • Store in a cool, dry area59° to 79° F (15° to 25° C)tamper evident sealed packetsdo not use any open or torn packets

Inactive Ingredients

Decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Crane Safety Burn Cream Label

Burn Cream with LidocaineBenzalkonium Chloride / Lidocaine HClTopical AntisepticAntiseptic and Pain relieving Cream for Minor Cuts, Scrapes and Burns0.9 g Packets25/BoxCRANE Safety®

* Please review the disclaimer below.