国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
SMG Pharmaceuticals, LLC
Salicylic Acid
Salicylic Acid 30 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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. Safety and effectiveness in pediatric patients has not been established.
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.
unapproved drug other
BENSAL HP- SALICYLIC ACID OINTMENT SMG PHARMACEUTICALS, LLC _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._ ---------- BENSAL TOPICAL OINTMENT Rx Only PRESCRIBING INFORMATION 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). 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 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. HP ® ® ® ® ® ® ® 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 完全なドキュメントを読む