Bensal Hp
Salicylic Acid
Smg Pharmaceuticals, Llc
Human Prescription Drug
NDC 63801-107Bensal Hp also known as Salicylic Acid is a human prescription drug labeled by 'Smg Pharmaceuticals, Llc'. National Drug Code (NDC) number for Bensal Hp is 63801-107. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Bensal Hp drug includes Salicylic Acid - 30 mg/g . The currest status of Bensal Hp drug is Active.
Drug Information:
| Drug NDC: | 63801-107 |
| 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: | Bensal Hp |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Smg Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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 - 30 mg/g
|
| 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: | UNAPPROVED DRUG OTHER |
| 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 Oct, 1998 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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. |
| 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: | SMG Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312888
1312997
|
| 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 |
|---|
| 63801-107-01 | 1 TUBE in 1 CARTON (63801-107-01) / 30 g in 1 TUBE | 01 Oct, 1998 | N/A | No |
| 63801-107-15 | 2 g in 1 TUBE (63801-107-15) | 01 Oct, 1998 | N/A | Yes |
| 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. |
Product Elements:
Bensal hp salicylic acid salicylic acid salicylic acid benzoic acid polyethylene glycol 400 polyethylene glycol 3350 quercus rubra bark
Drug Interactions:
Drug interactions it is not known if bensal hp ® interacts with other topical medications applied to the treatment area. the use of bensal hp ® with other topical drugs has not been studied.
Indications and Usage:
Indications and usage an external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. these conditions include complications associated with pyodermas. indicated also in the treatment of insect bites, burns and fungal infections.
Dosage and Administration:
Dosage and administration patients should be advised to follow these step-by-step instructions for application of bensal hp ® ointment: hands should be washed thoroughly. when using tubes, the tip of the tube should not come into contact with the area to be treated; the tube should be recapped tightly after each application. if applying with a cotton-tipped applicator, which is recommended, use once and discard. bensal hp ® ointment should be applied twice a day for best results. gently rinse the area to be treated with saline or water and then pat dry. bensal hp ® ointment can be applied directly to the wound or placed on dry gauze and then placed on the wound. wet-packs or wet-to-dry dressings are not recommended since they will dilute the ointment and decrease its effectiveness . bensal hp ® is designed to provide moisture to the wound. spread a generous quantity of bensal hp ® ointment evenly over the desired area to yield a thin continuous layer of approximately 1/8
Read more... of an inch of thickness. there may be a mild warming sensation, or slight burning, to the treated area for 3-5 minutes after application. if irritation occurs or symptoms persist after 10 days, discontinue use and consult your physician. try to keep the area being treated clean and exposed to air when possible. apply an appropriate dressing to shield the area from clothes or exposure to water or dirt. if there is no improvement in the wound within 7 days, consult your physician for further evaluation of the wound. if there is no response to the ointment at all, then the wound should be re-evaluated for other contributing factors to the wound healing process.
Contraindications:
Contraindications bensal hp ® is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols.
Adverse Reactions:
Adverse reactions bensal hp ® is generally well tolerated and non-irritating. a small percentage of patients may experience a temporary burning sensation upon application of the ointment.
Drug Interactions:
Drug interactions it is not known if bensal hp ® interacts with other topical medications applied to the treatment area. the use of bensal hp ® with other topical drugs has not been studied.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients has not been established.
Description:
Description bensal hp ® ointment contains 30 mg salicylic acid per gram in a base containing: benzoic acid, polyethylene glycol 400, polyethylene glycol 3350 and oak bark extract (qrb-7).
Clinical Pharmacology:
Clinical pharmacology the mechanism of action of bensal hp ® is not known. while the following animal data are available, their clinical significance is unknown. it has been demonstrated that bensal hp ® significantly reduces methicillin-resistant staphylococcus aureus (mrsa) protected by biofilms in wounds using porcine models. in addition, bensal hp ® stimulates re-epithelialization of second-degree burns in porcine models.
Clinical Studies:
Clinical studies a randomized, double-blind, placebo-controlled study evaluated the rate of wound re-epithelialization. four partial-thickness wounds (2Ã2 cm & 0.2 mm deep) were created under local anesthesia on the thighs of 13 normal, healthy, male volunteers with an electrokeratome. bensal hp ® substantially increased the rate of re-epithelialization by 63% over the vehicle alone (p<0.01) and 77% over untreated control (p<0.005).
How Supplied:
How supplied 30 g tube ndc 63801 - 0107 - 01 store at 20° c to 25° c (68° f to 77° f), excursions permitted between 15° c and 30° c (between 59° f and 86° f). brief exposure to temperatures up to 40° c (104° f) may be tolerated provided the mean kinetic temperature does not exceed 25° c (77° f); however, such exposure should be minimized.
Package Label Principal Display Panel:
Principal display panel - 30 gram tube carton topical ointment ndc 63801-0107-01 bensal hp ® rx only net wt. 30 grams principal display panel - 30 gram tube carton