NDC 0404-0743 Benzo-jel

Benzocaine

NDC Product Code 0404-0743

NDC 0404-0743-01

Package Description: 100 CUP, UNIT-DOSE in 1 CARTON > .56 g in 1 CUP, UNIT-DOSE

NDC Product Information

Benzo-jel with NDC 0404-0743 is a a human prescription drug product labeled by Henry Schein, Inc.. The generic name of Benzo-jel is benzocaine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Henry Schein, Inc.

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 Prescription 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.

Benzo-jel 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 200 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.

  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Allergens - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Henry Schein, Inc.
Labeler Code: 0404
Marketing Category: UNAPPROVED DRUG OTHER - 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: 07-03-2015 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: 12-31-2019 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.

Benzo-jel 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

Storage: Store Benzo-Jel At Controlled Room Temperature, Between 59 And 86°F (15 And 30°C).

Caution: Federal law (USA) prohibits dispensing without a prescription.Ingredients:Active: Each gram of 20% Benzocaine gel contains 200mg of Benzocaine USPInactive:Strawberry: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavor, FD&C Red # 40Bubble Gum: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavor, D&C Red # 28Mint: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavors, D&C Green # 5For professional use only.

Reorder #’S:Strawberry (#112-7286)Bubble Gum (#112-7287)Mint (#112-7288) Ndc # 0404-0742-01 (Strawberry) Ndc # 0404-0743-01 (Bubble Gum) Ndc # 0404-0741-01 (Mint)

Distributed by (in US only):HENRY SCHEIN, INC.135 DURYEA ROADMELVILLE, NY 11747 USAMADE IN USA246001      Rev Date: 05/2015

* Please review the disclaimer below.