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Bensal TOPICAL OINTMENT | Bensal HP [SMG Pharmaceuticals, LLC ] | BioPortfolio

13:34 EST 27th January 2019 | BioPortfolio

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Rx Only

Prescribing Information

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).

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.

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).

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.

Bensal HP is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols.

For external use only. Not to be used in eyes.

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.

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.

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.

Safety and effectiveness in pediatric patients has not been established.

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.

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

Topical OintmentNDC 63801-0107-01

Bensal

Rx only Net wt. 30 grams

Manufacturer

SMG Pharmaceuticals, LLC

Active Ingredients

Source

Drugs and Medications [0 Results]

None

Clinical Trials [0 Results]

None

PubMed Articles [1 Associated PubMed Articles listed on BioPortfolio]

Applications of Topical Oak Bark Extract in Dermatology: Clinical Examples and Discussion

The versatility of wound healing and anti-inflammatory agents can be assets to dermatologists when other therapies lack appropriate mechanisms of action, or when the risk to benefit ratio may be in qu...

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