Rx Only
Prescribing Information
DESCRIPTION: Bensal HP® ointment contains
60 mg benzoic acid and 30 mg salicylic acid per gram
in a base containing polyethylene glycol 400,
polyethylene glycol 3350 and 30 mg per gram of
oak bark extract (QRB-7).
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: A randomized, double-blind, placebo-controlled study evaluated the rate of wound
re-epithelialization. Four partial-thickness wounds
(2x2 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).
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.
CONTRAINDICATIONS: Bensal HP® is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols.
PRECAUTIONS: For external use only. Not to be used in eyes.
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.
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.
PEDIATRIC USE: Safety and effectiveness in pediatric patients has not been established.
HOW SUPPLIED:
· 15 g tube .............................. NDC 63801-107-09
· 30 g tube .............................. NDC 63801-107-01
Store at 15oC - 30oC (59oF - 86oF)
Distributed by:
AciesHealth, Inc.
1.866.550.5081
www.acieshealth.com BHP PI 020906
Application Instructions
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.
Minimum Inhibitory Concentration Testing of QRB-7
The minimum inhibitory concentrations (MIC) of QRB-7 are listed below in parts per million (PPM)*.
Microorganism QRB-7 Microorganism QRB-7
Microorganism Parts Per Million Microorganism Parts Per Million
|
Staphylococcus aureus, ATCC 6538 |
25,000 |
|
Pseudomonas stutzeri, ATCC 17588 |
50,000 | |
|
Salmonella choleraesuis, ATCC 10708 |
25,000 |
|
Salmonella typhi, ATCC 6539 |
12,500 | |
|
*Enterococcus faecalis , ATCC 19433 |
50,000 |
|
Enterobacter aerogenes, ATCC 15038 |
25,000 | |
|
Pseudomonas cepacia, ATCC 10856 |
3,125 |
|
Group D enterococcus |
50,000 | |
|
Staphylococcus epidermidis, ATCC 17917 |
12,500 |
|
Trichophyton mentagrophytes CDC y68+ |
50,000 | |
|
Alcaligenes faecalis, ATCC 8750 |
25,000 |
|
Rhodotorula rubra HTB Isolate |
50,000 | |
|
Streptococcus uberis, ATCC 27958 |
12,500 |
|
Enterobacter cloacae, Hosp/Envi isolate |
25,000 | |
|
Escherichia coli, ATC 25922 |
25,000 |
|
Escherichia coli, Hosp/Envi isolate |
25,000 | |
|
Klebsiella pneumoniae, ATCC 13883 |
25,000 |
|
Pseudomonas cepacia, Hosp/Envi isolate |
25,000 | |
|
Pseudomonas aeruginosa, ATCC 10145 |
25,000 |
|
Klebsiella pneumoniae, Hosp/Envi isolate |
25,000 | |
|
Shigella flexneri type 1A ATTC 9199 |
12,500 |
|
Staphylococcus aureus, Hosp/Envi isolate |
50,000 | |
|
Pseudomonas paucimobilis, ATCC 29837 |
1,563 |
|
Acinetobacter calcoaceticus, ATCC 17961 |
25,000 | |
|
Streptococcus sanguis, ATCC 10556 |
12,500 |
|
Alcaligenes faecalis, ATCC 337 |
25,000 | |
|
Acinetobacter lewoffii, ATCC 9957 |
25,000 |
|
Enterobacter cloacae, ATCC 23355 |
25,000 | |
|
Pseudomonas putida, HTB Isolate |
6,250 |
|
Achromobacter xylosoxidans, HTB isolate |
25,000 | |
|
Aeromonas sobria, ATCC 9071 |
25,000 |
|
Salmonella typhi, ATCC 19430 |
25,000 | |
|
Staphylococcus hominus, ATCC 27844 |
12,500 |
|
Listeria monocytogenes, ATCC 15313 |
12,500 | |
|
Staphylococcus haemolyticus, ATCC 29970 |
25,000 |
|
Serratia marcesans, ATCC 14756 |
25,000 | |
|
Staphylococcus saprophyticus, ATCC 15305 |
25,000 |
|
Serratia marcesans, ATCC 13880 |
25,000 | |
|
Staphylococcus simulans, ATCC 27848 |
25,000 |
|
Candida albicans, ATCC 10231 |
12,500 | |
|
Micrococcus lylae, ATCC 27566 |
50,000 |
|
Serratia marcesans, Hosp/Envi isolate |
25,000 | |
|
Streptococcus agalactiae, ATCC 13813 |
12,500 |
|
Salmonella enteritidis, ATCC 13076 |
25,000 | |
|
Streptococcus equisimilis, ATCC 9542 |
12,500 |
|
Escherichia coli, ATCC 11229 |
25,000 | |
|
Klebsiella oxytoca, ATCC 15764 |
25,000 |
*Data on file: AciesHealth, |
Proteus mirabilis, ATCC 9240 |
25,000 | |
|
Pseudomonas alcaligenes, ATCC 14909 |
12,500 |
|
|
|