{"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."],"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 (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)."],"contraindications":["CONTRAINDICATIONS Bensal HP ® is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols."],"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)."],"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 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."],"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."],"effective_time":"20241120","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."],"how_supplied_table":["
30 g tubeNDC 63801 - 0107 - 01
"],"id":"bb0edf4c-4215-4222-bb2a-d5e56984cbde","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."],"openfda":{},"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"],"pediatric_use":["PEDIATRIC USE Safety and effectiveness in pediatric patients has not been established."],"precautions":["PRECAUTIONS For external use only. Not to be used in eyes."],"set_id":"4b8ccee9-0f26-416d-a6e5-1261408df899","spl_product_data_elements":["Bensal HP Salicylic Acid SALICYLIC ACID SALICYLIC ACID BENZOIC ACID POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 QUERCUS RUBRA BARK"],"spl_unclassified_section":["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"],"spl_unclassified_section_table":["
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 .
MicroorganismQRB-7
MicroorganismParts Per Million
Staphylococcus aureus, ATCC 653825,000
Salmonella choleraesuis, ATCC 1070825,000
Enterococcus faecalis, ATCC 1943350,000
Pseudomonas cepacia, ATCC 108563,125
Staphylococcus epidermidis, ATCC 1791712,500
Alcaligenes faecalis, ATCC 875025,000
Streptococcus uberis ATCC 2795812,500
Escherichia coli, ATC 2592225,000
Klebsiella pneumoniae, ATCC 1388325,000
Pseudomonas aeruginosa, ATCC 1014525,000
Shigella flexneri type 1A ATTC 919912,500
Pseudomonas paucimobilis, ATCC 298371,563
Streptococcus sanguis, ATCC 1055612,500
Acinetobacter lewoffii, ATCC 995725,000
Pseudomonas putida, HTB Isolate6,250
Aeromonas sobria, ATCC 907125,000
Staphylococcus hominus, ATCC 2784412,500
Staphylococcus haemolyticus, ATCC 2997025,000
Staphylococcus saprophyticus, ATCC 1530525,000
Staphylococcus simulans, ATCC 2784825,000
Micrococcus lylae, ATCC 2756650,000
Streptococcus agalactiae ATCC 1381312,500
Streptococcus equisimilis ATCC 954212,500
Pseudomonas alcaligenes, ATCC 1490925,000
Klebsiella oxytoca, ATCC 1576412,500
Pseudomonas stutzeri, ATCC 1758850,000
Salmonella typhi, ATCC 653912,500
Enterobacter aerogenes, ATCC 1503825,000
Group D enterococcus50,000
Trichophyton mentagrophytes CDC y68+50,000
Rhodotorula rubra HTB Isolate50,000
Enterobacter cloacae, Hosp/Envi isolate25,000
Escherichia coli, Hosp/Envi isolate25,000
Pseudomonas cepacia, Hosp/Envi isolate25,000
Klebsiella pneumoniae, Hosp/Envi isolate25,000
Staphylococcus aureus, Hosp/Envi isolate50,000
Acinetobacter calcoaceticus, ATCC 1796125,000
Alcaligenes faecalis, ATCC 33725,000
Enterobacter cloacae, ATCC 2335525,000
Achromobacter xylosoxidans, HTB isolate25,000
Salmonella typhi, ATCC 1943025,000
Listeria monocytogenes, ATCC 1531312,500
Serratia marcesans, ATCC 1475625,000
Serratia marcesans, ATCC 1388025,000
Candida albicans, ATCC 1023112,500
Serratia marcensans, Hosp/Envi isolate25,000
Salmonella enteritidis, ATCC 1307625,000
Escherichia coli, ATCC 1122925,000
Proteus mirabilis, ATCC 924025,000
"],"storage_and_handling":["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."],"version":"9"}