Mediplast
Salicylic Acid
Medline Industries, Lp
Human Otc Drug
NDC 53329-410Mediplast also known as Salicylic Acid is a human otc drug labeled by 'Medline Industries, Lp'. National Drug Code (NDC) number for Mediplast is 53329-410. This drug is available in dosage form of Plaster. The names of the active, medicinal ingredients in Mediplast drug includes Salicylic Acid - 40 g/100g . The currest status of Mediplast drug is Active.
Drug Information:
| Drug NDC: | 53329-410 |
| 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: | Mediplast |
| 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: | Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medline Industries, Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Plaster |
| 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: | SALICYLIC ACID - 40 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 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 Aug, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | part358F |
| 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: | Medline Industries, LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 240559
1098584
|
| 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: | 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53329-410-09 | 1 APPLICATOR in 1 PACKET (53329-410-09) / 1.4 g in 1 APPLICATOR | 01 Aug, 2008 | N/A | No |
| 53329-410-59 | 25 PACKET in 1 BOX (53329-410-59) / 1 APPLICATOR in 1 PACKET / 1.4 g in 1 APPLICATOR | 01 Aug, 2008 | 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 corn, callus, and wart remover
Product Elements:
Mediplast salicylic acid phenol lanolin natural latex rubber balsam peru rosin talc terpineol salicylic acid salicylic acid orthocresol
Indications and Usage:
Uses for the removal of corns and calluses relieves pain by removing corns and calluses for the removal of common warts. the common wart is easily recognized by the rough âcauliflower-likeâ appearance of the surface for the removal of plantar warts on the bottom of the foot. the plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.
Warnings:
Warnings for external use only. this product contains natural rubber, which may cause allergic reactions. keep this and all drugs out of reach of children. in case of accidental ingestion, seek professional assistance or contact a poison control center immediately. stop using this product and see your doctor if discomfort persists for more than 72 hours do not use if you are diabetic or have poor blood circulation on irritated skin or on any area that is infected or reddened on moles, birthmarks, or warts with hair growing from them, genital warts, warts on the face, warts on mucous membranes such as warts inside the mouth, nose, anus, genitals or lips.
Do Not Use:
Warnings for external use only. this product contains natural rubber, which may cause allergic reactions. keep this and all drugs out of reach of children. in case of accidental ingestion, seek professional assistance or contact a poison control center immediately. stop using this product and see your doctor if discomfort persists for more than 72 hours do not use if you are diabetic or have poor blood circulation on irritated skin or on any area that is infected or reddened on moles, birthmarks, or warts with hair growing from them, genital warts, warts on the face, warts on mucous membranes such as warts inside the mouth, nose, anus, genitals or lips.
Dosage and Administration:
Directions wash affected area. may soak corn, callus or wart in warm water for 5 minutes. dry area thoroughly. cut pad to fit corn, callus or wart. apply medicated pad to area. remove medicated pad after 48 hours. repeat procedure every 48 hours for up to 14 days for corn/callus removal and up to 12 weeks for warts, until the problem has cleared.
Stop Use:
Stop using this product and see your doctor if discomfort persists for more than 72 hours
Package Label Principal Display Panel:
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