NDC 44224-0127 After Bite Xtra

Diphenhydramine Hcl

NDC Product Code 44224-0127

NDC 44224-0127-0

Package Description: 20 g in 1 TUBE

NDC 44224-0127-1

Package Description: 1 TUBE in 1 BOX > 20 g in 1 TUBE

NDC Product Information

After Bite Xtra with NDC 44224-0127 is a a human over the counter drug product labeled by Tender Corporation. The generic name of After Bite Xtra is diphenhydramine hcl. The product's dosage form is gel and is administered via topical form.

Labeler Name: Tender Corporation

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Xtra 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/g

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: Tender Corporation
Labeler Code: 44224
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: 03-01-2018 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.

Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]
Diphenhydramine Topical

Diphenhydramine Topical is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine topical medication prescribed?
Diphenhydramine, an antihistamine, is used to relieve the itching of insect bites, sunburns, bee stings, poison ivy, poison oak, and minor skin irritation.This medication...
[Read More]

* Please review the disclaimer below.

After Bite Xtra Product Label Images

After Bite Xtra 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

Diphenhydramine HCl 2%

Purpose

Topical Analgesic

Uses

  • For the temporary relief of pain and itching associated withinsect bitesminor burnssunburnminor skin irritationsminor cutsrashes due to poison ivy, poison oak, and poison sumac

Warnings

For external use only

Do Not Use

  • Do not useon large areas of the bodywith any other product containing diphenhydramine, even one taken by mouth

Ask A Doctor Before Use

  • Ask a doctor before useon chicken poxon measles

When Using

When using this product avoid contact with eyes.

Stop Use And Ask A Doctor If

  • Stop use and ask a doctor ifcondition worsensif symptoms persist for more than 7 days or clear up and occur again within a few days

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.

Directions

  • Directionsdo not use more than directedadults and children over 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: ask a doctor

Inactive Ingredients

Aloe Vera, Citric Acid, Ethyl Alcohol, Glycerin, Methocel, Methylparaben, Oat Beta Glucan, Propylparaben, Purified Water, Sodium Hydroxide, Tea Tree Oil, Vitamin E

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