OTC Skin Protectant Drug Product Claims and Ingredients
This article was originally published in The Rose Sheet
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<table cellspacing="1" cellpadding="7" width="100%" border="1"> <tbody> <tr> <td valign="top" colspan="2"> <p align="center"> <b><font face="Times" size="5">OTC Skin Protectant Drug Product Claims and Ingredients</font></b> </p> </td> </tr> <tr> <td valign="top" colspan="2"> <br /> <br /> <p> <b><i><font face="Times" size="1"><font size="2">The following table, compiled by "The Rose Sheet," lists the Category I indications proposed by FDA in the Final Monograph on skin protectant drug products. Opposite the indications are the proposed Category I ingredients for use in products making those claims.</font></font></i></b> </p> </td> </tr> <tr> <td valign="top" width="48%" bgcolor="#ffffff"> <p align="center"> <b><font face="Helvetica Condensed" size="1"><font size="2">Indications</font></font></b> </p> </td> <td valign="top" width="52%" bgcolor="#ffffff"> <p> <b><font face="Helvetica Condensed"><font size="2">Ingredients and Concentrations</font></font></b> </p> </td> </tr> <tr> <td valign="top" width="48%" height="19"> <p> <font face="Helvetica Condensed" size="2"><font size="3">"Temporarily protects minor: cuts, scrapes, burns."</font></font> </p> </td> <td valign="top" width="52%" height="19"> <p> <font face="Helvetica Condensed">Allantoin (0.5%-2%)<br /> Cocoa Butter (50%-100%)<br /> Cod Liver Oil (5%-13.56% w/ specifications)<br /> Hard Fat (50%-100%)<br /> Lanolin (12.5%-50%)<br /> Mineral Oil (50%-100%; 30%-35% w/colloidal oatmeal)<br /> Petrolatum (30%-100%)</font> </p> </td> </tr> <tr> <td valign="top" width="48%" height="19"> <p> <font face="Helvetica Condensed">"Temporarily protects chapped or cracked skin" followed by the optional statement "helps protect from the drying effects of wind and cold weather."</font> </p> </td> <td valign="top" width="52%" height="19"> <p> <font face="Helvetica Condensed">Allantoin (0.5%-2%)<br /> Cocoa Butter (50%-100%)<br /> Cod Liver Oil (5%-13.56% w/specifications)<br /> Dimethicone (1%-30%)<br /> Glycerin (20%-45%)<br /> Hard Fat (50%-100%)<br /> Lanolin (12.5%-50%)<br /> Mineral Oil (50%-100%; 30%-35% w/ colloidal oatmeal)<br /> Petrolatum (30%-100%)<br /> White Petrolatum (30%-100%)</font> </p> </td> </tr> <tr> <td valign="top" width="48%" height="19"> <p> <font face="Helvetica Condensed">"Dries the oozing and weeping of poison ivy, oak and sumac."</font> </p> </td> <td valign="top" width="52%" height="19"> <p> <font face="Helvetica Condensed">Aluminum Hydroxide Gel (.15%-5%)<br /> Calamine (1%-25%)<br /> Kaolin (4%-20%)<br /> Zinc Acetate (0.1%-2%)<br /> Zinc Carbonate (0.2%-2%)<br /> Zinc Oxide (1%-25%)</font> </p> </td> </tr> <tr> <td valign="top" colspan="2" height="19"> <p> <b><i><font face="Times" size="1"><font size="2">Additional indications apply specifically to colloidal oatmeal, sodium bicarbonate and topical starch.</font></font></i></b> </p> </td> </tr> </tbody> </table> |