Quickmend
Benzethonium Chloride
Equibal, Inc.
Human Otc Drug
NDC 53228-230Quickmend also known as Benzethonium Chloride is a human otc drug labeled by 'Equibal, Inc.'. National Drug Code (NDC) number for Quickmend is 53228-230. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Quickmend drug includes Benzethonium Chloride - .09 mg/9mL . The currest status of Quickmend drug is Active.
Drug Information:
| Drug NDC: | 53228-230 |
| 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: | Quickmend |
| 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: | Liquid |
| 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 - .09 mg/9mL
|
| 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 Apr, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 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. |
| 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 |
|---|
| 53228-230-01 | 9 mL in 1 CONTAINER (53228-230-01) | 01 Apr, 2016 | N/A | No |
| 53228-230-02 | 4.5 mL in 1 BOTTLE, PUMP (53228-230-02) | 01 Apr, 2016 | 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 protect against cold sore/fever blisters.
Product Elements:
Quickmend benzethonium chloride benzethonium chloride benzethonium behentrimonium methosulfate levomenol butylene glycol cetyl alcohol chamomile chlorhexidine gluconate dimethicone spearmint menthyl lactate, (-)- octyldodecanol phenoxyethanol polyquaternium 37 (200 mpa.s) rosemary oil stearic acid water hamamelis virginiana top
Indications and Usage:
Uses: treats cold sores/fever blisters. for the pain, tingling, itching, and burning associated with cold sores. may be used as an antiseptic to help clean or dry cold sores and fever blisters. may also be used for other skin irritations or minor burns to soothe, cool and relieve itching.
Warnings:
Warnings: for external use only. there may be a brief, very cold sensation on first application. if sore worsens or does not improve, contact a health care professional. avoid contact with eyes. do not swallow.
Dosage and Administration:
Directions: for adults and children 2 years and older. intended to be used at first indications of a cold sore. clean and dry affected area. apply quickmend⢠with a small piece of clean tissue or swab. best when used at first sign of outbreak. use 3 to 4 times during the day.
Package Label Principal Display Panel:
Quickmend product label quickmend ⢠for cold sore relief get cool, quick relief patented formula for quick soothing results from cold sores and fever blisters. treat it as soon as you feel it + get cool, quick relief! quickmend ⢠new! convenient pump dispenser drug facts active ingredient purpose benzethonium chloride 0.2% w/w protects against cold sores/fever blisters uses: treats cold sores/fever blisters. for the pain, tingling, itching, and burning associated with cold sores. may be used as an antiseptic to help clean or dry cold sores and fever blisters. may also be used for other skin irritations or minor burns to soothe, cool, and relieve itching. warnings: for external use only. there may be a brief, very cold sensation on first application. if sore worsens or does not improve, contact a health care professional. avoid contact with eyes. do not swallow. keep this and all drugs out of the reach of children. in case of accidental ingestion, seek professional assistance or call poison control center. directions: for adults and children 2 years and older. intended to be used at first indications of a cold sore. clean and dry affected area. apply quickmend⢠with a small piece of clean tissue or swab. best when used at first signe of outbreak. use 3 to 4 times during the day. other ingredients: behentrimonium methosulfate, bisabolol, butylene glycol, cetyl alcohol, chamomilla (matricaria recutita) extract, chlorhexidine gluconate, dimethicone, mentha spicata (spearmint) oil, menthyl lactate, octylodecanol, phenoxyethanol, polyquaterniuim-37, rosemary (rosmarinus officinalist) leaf oil, stearic acid, water (aqua), witch hazel (hamamelis virginiana) extract other: store in a cool dark area. not to exceed 78 o f (26 o c). questions or comments? call us toll free at 1(800)247-2405. tuesday â friday 8am-6pm et. equibal labs®, po box 180,unionville, ny 10988. retain this package for directions and information . quickmend ⢠cold sore relief *as always, results may vary. us patent #8,603,550 4.5 m./0.15oz. getquickmend.com mad in the usa. *as always, results may vary. quickmend ⢠quickmend label quickmend box label
Further Questions:
Questions or comments? other: call us toll free at 1 (800) 247-2405 tuesday - friday 8 a.m. - 6 p.m. est. equibal labs®, unionville, ny 10988. retain this package for directions and information. other: store in a cool dark area. not to exceed 78°f (26°c)