What safe and effective alternatives may serve to overcome some of the associated challenges, while still maintaining a combination of ease of set up and removal, efficacy, duration of efficacy and acceptable safety profiles? The “holy grail” of topical anesthetic agent(s) or device(s) will satisfy the needs while eliminating the challenges. “Unicorn” BLT topical compounds (or other effective topical anesthetic), have an extended shelf life, be compliant when produced and supplied in bulk, have a rapid onset of action, both an adequate duration, a simple, painless method of administration and an effective method of API delivery into the skin while limiting systemic entry. when supplied in multi-use jars, risk of cross contamination. product quality assurance and uniformity.lack of modular capability (all three in combination may not always be medically necessary),.In a 2012, study using it in laser procedures, it was shown to be more effective than other competitive approved topical numbing creams, such as EMLA or LMX5.Ĭhallenges procuring, storing and using this type of topical anesthetic include (among others): Compounded BLT numbing cream has the reputation of being very effective. When one prescription is supplied based on order from the clinician, yet used on more than one patient, the clinician is exposed to medico-legal risks in the event of a FDA or State Health Department audit, such as in the case of an adverse event. Compounded BLT numbing creams are supposed to be supplied on an individual patient basis, in accordance with US FDA policies. When the container is used on multiple patients, often by multiple clinicians, there is an inherent risk that microbes of other contaminants may be passed on to other who are being treated using the same container. There is a recent 2016, case where this adverse event did, in fact, cause corneal damage.Īnother risk associated with multi-use jars or tubes of BLT numbing cream is the risk of cross-contamination. BLT numbing creams that are gritty also open the risk for adverse events, such as grit causing corneal damage in the event it enters the eye. The grit is often the undissolved API’s that do not enter into the skin and therefore do not improve efficacy. It is often typical, that in concentrations above 20%, 4%, 2% that the active pharmaceutical ingredients (API’s) do not stay in solution and therefore present a gritty cream. These concentrations are well above what is required to appropriately numb the skin according to the United States Food and Drug Administration (US FDA). Many of the BLT numbing cream compounds are made in very high concentrations. They are made in various concentrations ranging from 20%, 4%, 2% to 20%, 10%, 10% respectively, benzocaine, lidocaine, tetracaine. BLT numbing creams are know for their strong positive effect.
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