NDC 44224-0203 Adventure First Aid .5 Tin

Benzocaine, Alcohol, Benzalkonium Chloride

NDC Product Code 44224-0203

NDC 44224-0203-1

Package Description: 1 KIT in 1 BOX * .7 mL in 1 PACKAGE (52124-0017-1) * .8 mL in 1 PACKAGE (52124-0001-1) * .5 g in 1 TUBE (52124-0003-1) * .5 mL in 1 PACKAGE (52124-0008-1)

NDC Product Information

Adventure First Aid .5 Tin with NDC 44224-0203 is a a human over the counter drug product labeled by Tender Corporation. The generic name of Adventure First Aid .5 Tin is benzocaine, alcohol, benzalkonium chloride. The product's dosage form is kit and is administered via oral; topical form.

Labeler Name: Tender Corporation

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • MINERAL OIL (UNII: T5L8T28FGP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Oral - Administration to or by way of the mouth.
  • 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: Tender Corporation
Labeler Code: 44224
FDA Application Number: part333A 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: 10-01-2015 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.

Adventure First Aid .5 Tin 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 - Antiseptic

Benzalkonium Chloride 0.13%

Purpose - Antiseptic

Antiseptic

Use - Antiseptic

For Professional and hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warnings, Precautions And Directions - Antiseptic

For External use only.Keep out of Reach of Children.Stop use if unusual redness, swelling or other symptoms occur, consult a physician immediately.Do not uses in eyes or over large areas of the body.Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive Ingredients - Antiseptic

Purified Water

Active Ingredient - Alcohol Prep Pad

Isopropyl Alcohol 70%

Use - Alcohol Prep Pad

For preparation of the skin before injection

Warnings, Precautions And Directions - Alcohol Prep Pad

For External Use OnlyFlammable - Keep away from fire or flameDo Not Use - with electrocautery, in eyesStop Use and Ask a Doctor if - Irritation or redness develop and persists for more than 72 hoursKeep out of Reach of ChildrenIf swallowed, get medical help or contact a poison control center right away.Tear Open packet, unfold and use as and wipe injection site vigorously and discard.Store at Room Temperature

Active Ingredients - Insect Relief Pad

Benzocaine 6%SD alcohol 60%

Purpose - Insect Relief Pad

Topical Anesthetic - Antiseptic

Use - Insect Relief Pad

For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites

Warnings, Precautions And Directions - Insect Relief Pad

Clean intended area thoroughly with pad. Discard after single useWarnings: For external use only.Avoid contact with eyes. If this happens, rinse thoroughly with waterIf swallowed, get medical help or contact a Poison Control Center right awayFlammable - keep away from fire or flameDo not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

Active Ingredients - Triple Antibiotic Ointment

Bacitracin Zinc 400 unitsNeomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)Polymyxin B Sulfate 5000 units

Purpose - Triple Antibiotic Ointment

Triple Antibiotic

Use - Triple Antibiotic Ointment

To help prevent infection in: minor cuts; scrapes and burns

Warnings, Precautions And Directions - Triple Antibiotic Ointment

For external use only.Do not use: in eyes; over large areas of the body;If allergic to any of the ingredients; for more than one week unless directed by a physicianStop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops.Keep out of reach of children.If ingested, contact a Poison Control Center right awayDirections: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage.

* Please review the disclaimer below.