Scar Zone Burn Topical Analgesic And Antiseptic

Lidocaine, Benzalkonium Chloride


Cca Industries, Inc.
Human Otc Drug
NDC 61543-6174
Scar Zone Burn Topical Analgesic And Antiseptic also known as Lidocaine, Benzalkonium Chloride is a human otc drug labeled by 'Cca Industries, Inc.'. National Drug Code (NDC) number for Scar Zone Burn Topical Analgesic And Antiseptic is 61543-6174. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Scar Zone Burn Topical Analgesic And Antiseptic drug includes Benzalkonium Chloride - .13 g/100g Lidocaine - 2 g/100g . The currest status of Scar Zone Burn Topical Analgesic And Antiseptic drug is Active.

Drug Information:

Drug NDC: 61543-6174
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Scar Zone Burn Topical Analgesic And Antiseptic
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Lidocaine, Benzalkonium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Cca Industries, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:BENZALKONIUM CHLORIDE - .13 g/100g
LIDOCAINE - 2 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 14 Jun, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part333A
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:CCA Industries, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1052429
1052431
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0018515617408
UPC stands for Universal Product Code.
NUI:N0000175682
M0000897
N0000175426
N0000175976
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:F5UM2KM3W7
98PI200987
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Amide Local Anesthetic [EPC]
Antiarrhythmic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Local Anesthesia [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Amides [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Amide Local Anesthetic [EPC]
Amides [CS]
Antiarrhythmic [EPC]
Local Anesthesia [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
61543-6174-51 TUBE in 1 BOX (61543-6174-5) / 14 g in 1 TUBE15 Mar, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose topical analgesic/anesthetic first aid antiseptic

Product Elements:

Scar zone burn topical analgesic and antiseptic lidocaine, benzalkonium chloride allantoin onion aloe vera leaf benzyl alcohol butylene glycol green tea leaf centella asiatica citric acid monohydrate glycerin tea tree oil methylisothiazolinone phenoxyethanol phytonadione polysorbate 60 propylene glycol water lidocaine lidocaine benzalkonium chloride benzalkonium

Indications and Usage:

Use for temporary relief of pain or discomfort, for first degree burns or superficial second degree burns and to help prevent infection in: minor burns, cuts, scrapes.

Warnings:

Warnings for external use only do not use for more than 1 week in or near eyes over an area larger than the palm of your hand ask a doctor before use if burn in severe ask a doctor or pharmacist before use if you have a history of heart disease or serious burns stop use and ask a doctor if increased redness or weeping or pain persist or clears up and occurs again within a few days keep out of reach of children in case of accidental ingestion, get medical help or contact a poison control center right away.

Do Not Use:

Warnings for external use only do not use for more than 1 week in or near eyes over an area larger than the palm of your hand ask a doctor before use if burn in severe ask a doctor or pharmacist before use if you have a history of heart disease or serious burns stop use and ask a doctor if increased redness or weeping or pain persist or clears up and occurs again within a few days keep out of reach of children in case of accidental ingestion, get medical help or contact a poison control center right away.

Dosage and Administration:

Directions adults and children 2 years and over clean the affected area lightly apply to the affected area 1 to 3 times daily may be covered with a sterile bandage children under 2 years, consult a doctor.

Stop Use:

Stop use and ask a doctor if increased redness or weeping or pain persist or clears up and occurs again within a few days

Package Label Principal Display Panel:

Package labeling: label2

Further Questions:

Questions or comments? call 1-800-595-6230


Comments/ Reviews:

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