Cornex
Lactic Acid, Salicylic Acid
Pella Pharmaceuticals Co. Ltd
Human Otc Drug
NDC 82160-238Cornex also known as Lactic Acid, Salicylic Acid is a human otc drug labeled by 'Pella Pharmaceuticals Co. Ltd'. National Drug Code (NDC) number for Cornex is 82160-238. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Cornex drug includes Lactic Acid - 2505 mg/15g Salicylic Acid - 2505 mg/15g . The currest status of Cornex drug is Active.
Drug Information:
| Drug NDC: | 82160-238 |
| 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: | Cornex |
| 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: | Lactic Acid, Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pella Pharmaceuticals Co. Ltd |
| 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: | LACTIC ACID - 2505 mg/15g
SALICYLIC ACID - 2505 mg/15g
|
| 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 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: | 25 Mar, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | M030 |
| 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: | Pella Pharmaceuticals Co. Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 244534
|
| 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: | 33X04XA5AT
O414PZ4LPZ
|
| 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: | Acidifying Activity [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82160-238-01 | 1 TUBE in 1 CARTON (82160-238-01) / 15 g in 1 TUBE | 25 Mar, 2010 | 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:
Properties cornex is a topical gel for the removal of warts and corns.
Product Elements:
Cornex lactic acid, salicylic acid alcohol hydroxypropyl cellulose, unspecified lactic acid lactic acid salicylic acid salicylic acid
Drug Interactions:
Drug interactions no interaction betyween lactic acid and salicylic acid and other drugs or substances are known or suspected.
Indications and Usage:
Indications cornex is used to remove warts and corns. a wart is a viral infection of the skin surface layer. the incubation period varies from a few weeks to several months. warts can be spread by contact of the virus with damaged skin, particularly if warm and moist. this is why one of the most common sources of infection is swimming pools. corns are hard, thick pads of skin caused by pressure and friction. they usually occur on the feet due to poorly fitting shoes. they can also occur on hands. cornex gel is suitable for use by adults, children and the elderly.
Warnings:
Warnings remember that warts are infectious. to prevent the infection spreading to others always keep to your own towel. do not walk about barefoot if warts are on the soles of your feet. be patient, it can take 6 to 12 weeks to completely remove the wart. do not use cornex on moles, brithmarks or unusual skin growths or near eyes or on mucous membranes. avoid use on broken or inflamed skin.
Dosage and Administration:
Dosage and administration remove any plaster and soak the wart in hot water for five minutes. dry with your own towel. rub the surface of the warts carefully with a pumice stone or emery board. apply cornex daily to the warts. use only enough cornex to cover the warts and avoid applying to the surrounding normal skin. allow cornex to dry and cover with plaster if the wart is large or on foot. continue using cemex daily until the wart is completely cleared and the ridge lines of the skin have been restored.
Contraindications:
Contraindications cornex is contraindicated in patients with known hypersensitivity to lactic acid and / or salicylic acid or to any other components of this product. do not use cornex if you are diabetic or suffer from poor blood circulation to your hands or feet.
Adverse Reactions:
Side effects avoid use on large areas of skin; as this may result in absorption of sufficient quantities to cause adverse effects.
Drug Interactions:
Drug interactions no interaction betyween lactic acid and salicylic acid and other drugs or substances are known or suspected.
How Supplied:
How supplied 15 g packs.
Package Label Principal Display Panel:
Secondary package secondary package
Primary package primary package