Finipil Pro/elec
Benzethonium Chloride
Equibal, Inc.
Human Otc Drug
NDC 53228-001Finipil Pro/elec also known as Benzethonium Chloride is a human otc drug labeled by 'Equibal, Inc.'. National Drug Code (NDC) number for Finipil Pro/elec is 53228-001. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Finipil Pro/elec drug includes Benzethonium Chloride - 195 mg/100mL . The currest status of Finipil Pro/elec drug is Active.
Drug Information:
| Drug NDC: | 53228-001 |
| 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: | Finipil Pro/elec |
| 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: | Benzethonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Equibal, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | BENZETHONIUM CHLORIDE - 195 mg/100mL
|
| 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: | 01 Mar, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 Jun, 2026 |
| 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: | Equibal, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1372490
|
| 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. |
| UNII: | PH41D05744
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53228-001-01 | 75 mL in 1 TUBE (53228-001-01) | 01 Mar, 2013 | N/A | No |
| 53228-001-02 | 3.6 mL in 1 PACKET (53228-001-02) | 01 Mar, 2013 | N/A | No |
| 53228-001-03 | 236 mL in 1 BOTTLE, PUMP (53228-001-03) | 01 Mar, 2013 | N/A | No |
| 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 purpose antiseptic
Product Elements:
Finipil pro/elec benzethonium chloride benzethonium chloride benzethonium behentrimonium methosulfate levomenol butylene glycol cetyl alcohol chlorhexidine gluconate dimethicone matricaria recutita menthyl lactate, (-)- octyldodecanol phenoxyethanol polyquaternium-37 (25000 mpa.s) stearic acid water hamamelis virginiana top
Indications and Usage:
Use(s) uses(s) first aid to help prevent bacterial contamination in minor cuts, scrapes, and burns. cools, soothes, and moisturizes after hair removal. recommended for repeated use.
Warnings:
Warnings do not use in conjunction warnings for external use only do not use in conjunction with products containing acids
When Using:
When using this product when using this product do not get into eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
Directions directions apply a small amount after nufree® or electric hair removal
Stop Use:
Stop use and ask a doctor if stop use and ask a doctor if irritation and redness develop
Package Label Principal Display Panel:
Finipil pro/elec 3.6 ml finipil ® antiseptic cream for professional use only soothes â cools â moisturizes protects against infection pro/elec â â â noncomedogenic 3.6 ml. drug facts active ingredient purpose benzethonium chloride 0.2% w/w antiseptic uses(s) first aid to help prevent bacterial contamination in minor cuts, scrapes, and burns. cools, soothes, and moisturizes after hair removal. recommended for repeated use. warnings for external use only ask a doctor if pregnant or breast feeding. when using this product do not get into eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask a doctor if irritation and redness develop do not use in conjunction with products containing acids. keep out of reach of children if swallowed, get medical help or contact a poison control center right away. directions apply a small amount of nufree® or electric hair removal. inactive ingredients bethecrimium methosulfate, bisabolol, cetyle alcohol, chlorhexidine gluconate, dimethicone, matricaria (chamomile recutital) extract, menthyl lactate, octylodecanoil, phenoxyethanol, phenoxyethanol, polyquaterniuim-37, stearic acid, water, witch hazel (hamamelis virginiana) extract equibal labs www.nufree.com made in u.s.a. 800-247-2405 not tested on animals patent# 8,603,550 equibal finipil elecpro1 label equibal finipil elecpro2 label
Finipil pro /elec 236 ml finipil ® antiseptic cream pro/elec soothes â cools â moisturizes protects against infection noncomedogenic for professional use only 8 fl oz 236 ml drug facts active ingredient purpose benzethonium chloride 0.2% w/w antiseptic uses(s) first aid to help prevent bacterial contamination in minor cuts, scrapes, and burns. cools, soothes, and moisturizes after hair removal. recommended for repeated use. warnings for external use only ask a doctor if pregnant or breast feeding. when using this product do not get into eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask a doctor if irritation and redness develop do not use in conjunction with products containing acids. keep out of reach of children if swallowed, get medical help or contact a poison control center right away. directions apply a small amount of nufree® or electric hair removal. inactive ingredients bethecrimium methosulfate, bisabolol, cetyle alcohol, chlorhexidine gluconate, dimethicone, matricaria (chamomile recutital) extract, menthyl lactate, octylodecanoil, phenoxyethanol, phenoxyethanol, polyquaterniuim-37, stearic acid, water, witch hazel (hamamelis virginiana) extract equibal labs 800-247-2405 nufree.com made in u.s.a. not tested on animals patent# 8,603,550 finipil proelec 236 ml