Salicylic Acid
Medicated Corn Removers
Hudson Health Llc
Human Otc Drug
NDC 72446-005Salicylic Acid also known as Medicated Corn Removers is a human otc drug labeled by 'Hudson Health Llc'. National Drug Code (NDC) number for Salicylic Acid is 72446-005. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Salicylic Acid drug includes Benzethonium Chloride - .2 mg/9mL Dyclonine Hydrochloride - .75 mg/9mL . The currest status of Salicylic Acid drug is Active.
Drug Information:
| Drug NDC: | 72446-005 |
| 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: | Salicylic Acid |
| 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: | Medicated Corn Removers |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hudson Health Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| 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 - .2 mg/9mL
DYCLONINE HYDROCHLORIDE - .75 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 Sep, 2018 |
| 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, 2024 |
| 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: | Hudson Health LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1048366
|
| 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
ZEC193879Q
|
| 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 |
|---|
| 72446-005-09 | 9 mL in 1 BOTTLE, WITH APPLICATOR (72446-005-09) | 01 Sep, 2018 | 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 first aid antiseptic topical analgesic
Product Elements:
Salicylic acid medicated corn removers acetone amyl acetate castor oil ethyl acetate pyroxylin alcohol benzethonium chloride benzethonium dyclonine hydrochloride dyclonine
Indications and Usage:
Uses first aid to prevent bacteria contamination in minor cuts and scrapes
Warnings:
Warnings for external use only. flammable: do not use while smoking or near heat or flame. do not use in the eyes over large areas of the body longer than 1 week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes ask a doctor before use if you have deep puncture wounds deep cuts animal bites serious bleeding diabetes poor circulation serious burns when using this product do not sotre at temperaure above 120of intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. stop use and ask a doctor if conditions persists or gets worse infection occurs keep out of reach of children. if swallowed, get medical help or call a poison control center right away.
Do Not Use:
Warnings for external use only. flammable: do not use while smoking or near heat or flame. do not use in the eyes over large areas of the body longer than 1 week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes ask a doctor before use if you have deep puncture wounds deep cuts animal bites serious bleeding diabetes poor circulation serious burns when using this product do not sotre at temperaure above 120of intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. stop use and ask a doctor if conditions persists or gets worse infection occurs keep out of reach of children. if swallowed, get medical help or call a poison control center right away.
When Using:
When using this product do not sotre at temperaure above 120of intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Dosage and Administration:
Directions clean affected area apply a small amount on the area 1-3 times daily let dry a second coating may be applied for extra protection to remove, apply more liquid bandage and quickly wipe off finger nail polish remover may dissolve liquid bandage
Stop Use:
Stop use and ask a doctor if conditions persists or gets worse infection occurs
Package Label Principal Display Panel:
Principal display panel comfortzone maximum strength liquid bandage benzethonium chloride dyclonine hydrochloride topical anagesic & antiseptic to help prevent infection for small cut & wounds antiseptic formula dries quickly to form an invisible protective cover that is flexible net 1.0 fl oz (29.6 ml) amazon_liquid bandage_50-033am.jpg amazon_liquid bandage_53-033am.jpg
Further Questions:
Questions 1-877-237-0194