Sambria Pharmaceuticals Topical Lidocaine Creams differ from other products in more than one way.įirst, Sambria Pharmaceuticals Topical Lidocaine Creams are supplied in the unique single-use sanitary packets. They are both supplied in single-use, sanitary packets that contain 4 mL (grams by weight) of the proprietary formulation of the lidocaine products. NeuroMed 7 (4% topical lidocaine) and NeuroMed AR (5% topical lidocaine) are the name brands for the Sambria Pharmaceuticals Topical Lidocaine Cream products. There is NeuroMed 7 also included in the NeuroMed BLT Combination package, which is the clinical convenience package that also includes, NeuroMed FA (topical benzocaine) and NeuroMed LA (topical tetracaine). The Sambria Pharmaceuticals Topical Lidocaine products are NeuroMed 7 sanitary, single-use packets and multi-use tubes. Those products that are not manufactured in US FDA approved and monitored facilities run the risk of serious defects, flaws, inaccurate dosing, dangerous pathogenic microbes and more. Always ensure that your OTC lidocaine cream is made in US FDA approved and monitored facilities for the best quality and safety standards. When used as directed these products are considered safe and effective for adults and children two years of age or older. While implementing these methods may possibly improve the penetration of the active pharmaceutical ingredient (API) in the lidocaine cream OTC, it may also increase the risk of systemic absorption which in high doses can lead to serious adverse health issues. When applying lidocaine cream OTC it is best not to pre-apply heat or cover with any form of dressing unless directed by a licensed physician. OTC lidocaine cream should be applied in a thin layer to the affected treatment area and massaged into the skin. OTC lidocaine cream should also only be used up to three to four times per day and only for up to seven days, unless otherwise directed by a licensed physician. Topical OTC lidocaine cream should only be used on small to medium surface areas, not large areas such as the entire back or even half the back. Consult your doctor before using any lidocaine topical cream for any reason. *This information is not intended for use as diagnosing or treating health related conditions. 5% topical lidocaine creams are approved for ano-rectal use, such as for the relief of pain, burn and itch for hemorrhoids. Topical lidocaine 4% is the highest concentration suggested and approved by the United States Food and Drug Administration (US FDA or FDA) for use on the skin. It numbs the skin where it is applied to a localized surface area. Topical lidocaine 4% is used to numb the skin. When the concentration for a lidocaine topical cream is 5% it must state that it is for ano-rectal use only in the product data box on its packaging. Another monograph that regulates ano-rectal products allows a maximum of 5% concentration for lidocaine topical creams. This means that lidocaine topical cream products can contain a maximum of 4% concentration or lower. The 21 CFR 348 Monograph allows a concentration of 4% for lidocaine topical cream products. The monograph for OTC lidocaine topical creams is the 21 CFR Tentative Final Monograph 348 External Analgesic Drug Products for Over the Counter Human Use. The United States Food and Drug Administration (US FDA) provides a standardized set of rules called a “monograph” that outlines allowable dosages, uses, packaging and related regulatory topics. Lidocaine topical cream is supplied in both prescription and over the counter (OTC) forms.
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