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Bensal HP Ointment

Generic Name: salicylic acid
Dosage Form: ointment

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

BensalHP ®
TOPICAL OINTMENT

Rx Only

Prescribing Information

Bensal HP Ointment 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).

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Bensal HP Ointment - 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 (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).

Indications and Usage for Bensal HP Ointment

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.

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.

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 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 is Bensal HP Ointment Supplied

15 g tube NDC 63801 - 0107 - 09
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)* .
Microorganism QRB-7
*
Data on file: 7 Oaks Pharmaceutical Corp., Easley, SC
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 by: Sonar Products Inc. • Carlstadt, NJ

For: 7 Oaks Pharmaceutical Corp. • Easley, SC • 877.723.6725

© 2010 7 Oaks Pharmaceuticals Corp.
BHP-PI TD 0512

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Topical Ointment

NDC 63801-0107-01

BensalHP ®

Rx only

Net wt. 30 grams

BENSAL HP 
salicylic acid ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63801-107
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (Salicylic Acid) Salicylic Acid 30 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Benzoic Acid  
Polyethylene glycol 400  
Polyethylene glycol 3350  
Quercus rubra bark  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:63801-107-01 1 TUBE in 1 CARTON
1 30 g in 1 TUBE
2 NDC:63801-107-09 1 TUBE in 1 CARTON
2 15 g in 1 TUBE
3 NDC:63801-107-12 1 TUBE in 1 CARTON
3 4 g in 1 TUBE
4 NDC:63801-107-13 12 DOSE PACK in 1 CARTON
4 2 g in 1 DOSE PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/01/1998
Labeler - SMG Pharmaceuticals, LLC (079332298)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc. 104283945 MANUFACTURE(63801-107)
Revised: 04/2014
 
SMG Pharmaceuticals, LLC
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