NDC 46122-653 Bite And Sting Relief Gnp

Benzocaine

NDC Product Code 46122-653

NDC 46122-653-34

Package Description: 85 g in 1 PACKAGE

NDC Product Information

Bite And Sting Relief Gnp with NDC 46122-653 is a a human over the counter drug product labeled by Amerisource Bergen Llc. The generic name of Bite And Sting Relief Gnp is benzocaine. The product's dosage form is spray and is administered via topical form.

Labeler Name: Amerisource Bergen Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Bite And Sting Relief Gnp 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 5 g/100g

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.

  • ALOE ARBORESCENS FLOWER (UNII: U449SE7IPV)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • CLOVE OIL (UNII: 578389D6D0)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ALCOHOL (UNII: 3K9958V90M)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CORN OIL (UNII: 8470G57WFM)

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: Amerisource Bergen Llc
Labeler Code: 46122
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: 01-18-2021 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 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.

Bite And Sting Relief Gnp Product Label Images

Bite And Sting Relief Gnp 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                                       Purpose

Benzocaine 5.0% ....................................... Pain Relief

Uses

For the temporary relief of pain and itching associated with insect bites.

Warnings For External Use Only.

Flammable: Do not use while smoking or near heat or flame


When using this product• avoid contact with the eyes• use only as directed.• do not puncture or incinerate.


Contents under pressure.


Do not store at temperatures above 120°F.


Stop use and ask a doctor if• condition worsens• symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of The Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Shake well• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.


Children under 2 years of age: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice Extract, Ascorbic Acid, Camphor, Chamomilla Recutita (Matricaria) Flower, Extract, Cholecalciferol, Diisopropyl Adipate, Eugenia Caryophyllus (Clove) Flower Oil, Fragrance, Mentha Piperita ( Peppermint) Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil,

PE -8 Dimethicone, Propylene lycol, Pyridoxine HCI, Retinyl Palmitate, SD Alcohol 40, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Tocopheryl Acetate, Zea Mays (Corn) Oil.

Questions?

888-793-8450

* Please review the disclaimer below.