NDC 44224-0014 After Bite Wipe Insect Sting Relief

Benzocaine,alcohol

NDC Product Code 44224-0014

NDC 44224-0014-1

Package Description: 1000 mg in 1 PACKAGE

NDC 44224-0014-2

Package Description: 100 PACKET in 1 BOX > 1000 mg in 1 PACKET

NDC Product Information

After Bite Wipe Insect Sting Relief with NDC 44224-0014 is a a human over the counter drug product labeled by Tender Corporation. The generic name of After Bite Wipe Insect Sting Relief is benzocaine,alcohol. The product's dosage form is swab and is administered via topical form.

Labeler Name: Tender Corporation

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

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.

After Bite Wipe Insect Sting Relief 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.

  • BENZOCAINE 6 mg/100mg
  • ALCOHOL 60 mg/100mg

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: Tender Corporation
Labeler Code: 44224
FDA Application Number: part333E 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: 09-01-2019 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.

After Bite Wipe Insect Sting Relief 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

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

First Aid Antibiotic

Topical Analgesic

Antiseptic

Use

For preparation of skin before injection.

First aid to help prevent infection in minor cuts, scrapes, and burns.

Temporarily relieves pain and itching due to minor stings and insect bites

Warnings

For external use only.Flammable - keep away from fire or flame

For external use only.

For external use only.Flammable, keep away from fire or flame.

Do Not Use

  • In the eyeswith electrocautery procedures

  • If you are allergic to any of the ingredientsin the eyesover large areas of the body

  • Over large areas of the bodyin the eyeson broken skin or deep puncture wounds

Stop Use And Ask A Doctor If

  • Irritation and redness developcondition persists for more than 72 hours

Symptoms persist for more than 7 days or clear up and occur again within a few days.

Condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days.

Keep Out Of Reach Of Children

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

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

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

Directions

Wipe Injection site vigorously and discard.

  • Adults and children 2 year of age and older: clean the affected area; apply a small amount to the area 1-3 times daily; may be covered with a sterile bandagechildren under 2 years of age: consult a doctor

  • Adults and children 2 year of age and older: apply to affected area not more than 3 to 4 times daily.children under 2 years of age: consult a doctor

Other Information

Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

Store at room temperature

Inactive Ingredient

Purified water

Purified water

Active Ingredients

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

Benzocaine, 6%SD alcohol, 60%

Ask A Doctor Before Use If You Have

  • Deep pumcture woundsanimal bitesserious burns

Inactive Ingredients

Mineral oil, petrolatum

* Please review the disclaimer below.