NDC 80069-011 Sj3

Lidocaine Hcl, Tetracaine Hcl, Benzocaine

NDC Product Code 80069-011

NDC 80069-011-01

Package Description: 118.294 mL in 1 BOTTLE, PUMP

NDC Product Information

Sj3 with NDC 80069-011 is a a human over the counter drug product labeled by Dermal Source, Inc.. The generic name of Sj3 is lidocaine hcl, tetracaine hcl, benzocaine. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2566289.

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.

Sj3 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.


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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • EDETATE SODIUM (UNII: MP1J8420LU)

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: Dermal Source, Inc.
Labeler Code: 80069
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: 08-15-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sj3 Product Label Images

Sj3 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

Otc - Purpose

Active Ingredients  PurposeLidocaine Hydrochloride   5% Topical AnestheticTetracaine Hydrochloride   1% Topical AnestheticBenzocaine 12% Topical Anesthetic

Indications & Usage

Uses: External Use Only. Do Not Swallow. Temporarily supplies pain relief to either intact or open skin due to pain sensitive procedures.

Warnings

WARNINGS -  Keep out reach of children

Otc - Do Not Use

  • Do not use if you haveseizures or liver diseaseif pregnant or breast feedinga known allergy or sensitivity to any of the components of this product. If sensitivity occurs, discontinue use, and seek medical attention. If condition worsens or symptoms persist for more than seven days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas.Avoid contact with eyes, in case of accidental contact with eyes, rinse immediately with copious amounts of eyewash and seek treatment by an eye care specialist. If accidentally swallowed, get medical help immediately.

Otc - When Using

When using this product you may notice temporary blanching or redness of the skin where liquid is applied.

Dosage & Administration

Directions:  Sensitivity test advised prior to use.Apply to intact skin to clean prior to application of predeadener. Use to wipe off predeadener. During procedure, swipe across skin and wait for numbness to develop (90 seconds). Not appropriate for eyeliner. You may reapply as necessary to continue anesthesia. Discontinue use if sensitivity occurs. Remove product before continuing with procedure.

Inactive Ingredient

Inactive Ingredients: Propylene Glycol, Ethoxydiglycol, Tetrasodium EDTA.

Storage And Handling

Other information: Store in a cool dark place or refrigerate. Discard after expiration date.

Otc - Questions

Questions? Contact distributor on product label.

* Please review the disclaimer below.