DailyMed Label: Bensal HP

DailyMed Label: Bensal HP

2023

DailyMed Prescription

Bensal HP

Salicylic Acid

SMG Pharmaceuticals, LLC

NDC: 63801-107

NDC: 63801-107

NDC: 63801-107

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).

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.

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.

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.

Bensal HP

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.

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.

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).

Topical Ointment NDC 63801-0107-01 Bensal HP ® Rx only Net wt. 30 grams PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton