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| Product NDC Code | 63801-107 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Bensal hp |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 312888, 1312997 |
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| Labeler Name | SMG Pharmaceuticals, LLC | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Bensal HP Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Bensal HP ® is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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).
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Bensal HP Salicylic Acid SALICYLIC ACID SALICYLIC ACID BENZOIC ACID POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 QUERCUS RUBRA BARK
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx Only Prescribing Information
Bensal HP ® inhibited all tested microbial strains, both Gram negative and Gram positive, in a Minimum Inhibitory Concentration (MIC) test against the following 49 select pathogens. Minimum Inhibitory Concentration Testing of QRB-7 The minimum inhibitory concentrations (MIC) of QRB-7 are listed below in parts per million (PPM) Data on file: 7 Oaks Pharmaceutical Corp., Easley, SC . Microorganism QRB-7 Microorganism Parts Per Million Staphylococcus aureus, ATCC 6538 25,000 Salmonella choleraesuis, ATCC 10708 25,000 Enterococcus faecalis, ATCC 19433 50,000 Pseudomonas cepacia, ATCC 10856 3,125 Staphylococcus epidermidis, ATCC 17917 12,500 Alcaligenes faecalis, ATCC 8750 25,000 Streptococcus uberis ATCC 27958 12,500 Escherichia coli, ATC 25922 25,000 Klebsiella pneumoniae, ATCC 13883 25,000 Pseudomonas aeruginosa, ATCC 10145 25,000 Shigella flexneri type 1A ATTC 9199 12,500 Pseudomonas paucimobilis, ATCC 29837 1,563 Streptococcus sanguis, ATCC 10556 12,500 Acinetobacter lewoffii, ATCC 9957 25,000 Pseudomonas putida, HTB Isolate 6,250 Aeromonas sobria, ATCC 9071 25,000 Staphylococcus hominus, ATCC 27844 12,500 Staphylococcus haemolyticus, ATCC 29970 25,000 Staphylococcus saprophyticus, ATCC 15305 25,000 Staphylococcus simulans, ATCC 27848 25,000 Micrococcus lylae, ATCC 27566 50,000 Streptococcus agalactiae ATCC 13813 12,500 Streptococcus equisimilis ATCC 9542 12,500 Pseudomonas alcaligenes, ATCC 14909 25,000 Klebsiella oxytoca, ATCC 15764 12,500 Pseudomonas stutzeri, ATCC 17588 50,000 Salmonella typhi, ATCC 6539 12,500 Enterobacter aerogenes, ATCC 15038 25,000 Group D enterococcus 50,000 Trichophyton mentagrophytes CDC y68+ 50,000 Rhodotorula rubra HTB Isolate 50,000 Enterobacter cloacae, Hosp/Envi isolate 25,000 Escherichia coli, Hosp/Envi isolate 25,000 Pseudomonas cepacia, Hosp/Envi isolate 25,000 Klebsiella pneumoniae, Hosp/Envi isolate 25,000 Staphylococcus aureus, Hosp/Envi isolate 50,000 Acinetobacter calcoaceticus, ATCC 17961 25,000 Alcaligenes faecalis, ATCC 337 25,000 Enterobacter cloacae, ATCC 23355 25,000 Achromobacter xylosoxidans, HTB isolate 25,000 Salmonella typhi, ATCC 19430 25,000 Listeria monocytogenes, ATCC 15313 12,500 Serratia marcesans, ATCC 14756 25,000 Serratia marcesans, ATCC 13880 25,000 Candida albicans, ATCC 10231 12,500 Serratia marcensans, Hosp/Envi isolate 25,000 Salmonella enteritidis, ATCC 13076 25,000 Escherichia coli, ATCC 11229 25,000 Proteus mirabilis, ATCC 9240 25,000
Manufactured for: EPI Health, LLC • Charleston, SC 29403 For: 7 Oaks Pharmaceutical Corp. • Easley, SC • 877.723.6725 © 2010 7 Oaks Pharmaceuticals Corp. BHP-PI TD 0517
| Microorganism | QRB-7 |
|---|---|
| Staphylococcus aureus, ATCC 6538 | 25,000 |
| Salmonella choleraesuis, ATCC 10708 | 25,000 |
| 50,000 | |
| Pseudomonas cepacia, ATCC 10856 | 3,125 |
| Staphylococcus epidermidis, ATCC 17917 | 12,500 |
| Alcaligenes faecalis, ATCC 8750 | 25,000 |
| Streptococcus uberis ATCC 27958 | 12,500 |
| Escherichia coli, ATC 25922 | 25,000 |
| Klebsiella pneumoniae, ATCC 13883 | 25,000 |
| Pseudomonas aeruginosa, ATCC 10145 | 25,000 |
| Shigella flexneri type 1A ATTC 9199 | 12,500 |
| Pseudomonas paucimobilis, ATCC 29837 | 1,563 |
| Streptococcus sanguis, ATCC 10556 | 12,500 |
| Acinetobacter lewoffii, ATCC 9957 | 25,000 |
| Pseudomonas putida, HTB Isolate | 6,250 |
| Aeromonas sobria, ATCC 9071 | 25,000 |
| Staphylococcus hominus, ATCC 27844 | 12,500 |
| Staphylococcus haemolyticus, ATCC 29970 | 25,000 |
| Staphylococcus saprophyticus, ATCC 15305 | 25,000 |
| Staphylococcus simulans, ATCC 27848 | 25,000 |
| Micrococcus lylae, ATCC 27566 | 50,000 |
| Streptococcus agalactiae ATCC 13813 | 12,500 |
| Streptococcus equisimilis ATCC 9542 | 12,500 |
| Pseudomonas alcaligenes, ATCC 14909 | 25,000 |
| Klebsiella oxytoca, ATCC 15764 | 12,500 |
| Pseudomonas stutzeri, ATCC 17588 | 50,000 |
| Salmonella typhi, ATCC 6539 | 12,500 |
| Enterobacter aerogenes, ATCC 15038 | 25,000 |
| Group D enterococcus | 50,000 |
| Trichophyton mentagrophytes CDC y68+ | 50,000 |
| Rhodotorula rubra HTB Isolate | 50,000 |
| Enterobacter cloacae, Hosp/Envi isolate | 25,000 |
| Escherichia coli, Hosp/Envi isolate | 25,000 |
| Pseudomonas cepacia, Hosp/Envi isolate | 25,000 |
| Klebsiella pneumoniae, Hosp/Envi isolate | 25,000 |
| Staphylococcus aureus, Hosp/Envi isolate | 50,000 |
| Acinetobacter calcoaceticus, ATCC 17961 | 25,000 |
| Alcaligenes faecalis, ATCC 337 | 25,000 |
| Enterobacter cloacae, ATCC 23355 | 25,000 |
| Achromobacter xylosoxidans, HTB isolate | 25,000 |
| Salmonella typhi, ATCC 19430 | 25,000 |
| Listeria monocytogenes, ATCC 15313 | 12,500 |
| Serratia marcesans, ATCC 14756 | 25,000 |
| Serratia marcesans, ATCC 13880 | 25,000 |
| Candida albicans, ATCC 10231 | 12,500 |
| Serratia marcensans, Hosp/Envi isolate | 25,000 |
| Salmonella enteritidis, ATCC 13076 | 25,000 |
| Escherichia coli, ATCC 11229 | 25,000 |
| Proteus mirabilis, ATCC 9240 | 25,000 |
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.CLINICAL STUDIES A randomized, double-blind, placebo-controlled study evaluated the rate of wound re-epithelialization. Four partial-thickness wounds (2×2 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).
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.PEDIATRIC USE Safety and effectiveness in pediatric patients has not been established.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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.
| 30 g tube | NDC 63801 - 0107 - 01 |
Storage and handling
Information about safe storage and handling of the drug product.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.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS For external use only. Not to be used in eyes.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API