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<p class="DocumentTitle"><strong>BANALG- methyl salicylate and menthol lotion </strong><br>Rebel Distributors Corp<br></p>
<p class="disclaimer">Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.</p>
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<h1>Banalg Drug Facts</h1>
<div class="Contents">
<div class="Section" data-sectionCode="48780-1">
<a name="section-1"></a><p></p>
</div>
<div class="Section" data-sectionCode="55106-9">
<a name="i4i_OTC_Active_Ingredient_id_2dd5b31d-0d42-49e2-ba46-d930f372b5b5"></a><a name="section-1"></a><p></p>
<h1>Active ingredient</h1>
<p class="First">Methyl Salicylate 14.0%</p>
<p>Menthol 3.0%</p>
</div>
<div class="Section" data-sectionCode="55105-1">
<a name="i4i_OTC_Purpose_id_b98043f6-b0c4-41a3-ba18-050c40e51dd5"></a><a name="section-2"></a><p></p>
</div>
<div class="Section" data-sectionCode="50565-1">
<a name="i4i_OTC_Keep_Away_Children_id_3cc9a954-7e72-4810-aa96-74a120b4ca81"></a><a name="section-3"></a><p></p>
<h1>Keep Out of Reach of Children</h1>
</div>
<div class="Section" data-sectionCode="34067-9">
<a name="i4i_indications_id_8f4a400b-d0f8-4d25-a931-00e3b459e2df"></a><a name="section-4"></a><p></p>
<h1>Uses</h1>
<p class="First">For the temporary relief of minor ach3es and <span class="product-label-link" type="condition" conceptid="4329041" conceptname="Pain">pains</span> of muscles and joints associated with <span class="product-label-link" type="condition" conceptid="4291025" conceptname="Arthritis">arthritis</span> and <span class="product-label-link" type="condition" conceptid="138845" conceptname="Rheumatism">rheumatism</span>. Also good for simple <span class="product-label-link" type="condition" conceptid="134736" conceptname="Backache">backache</span>, <span class="product-label-link" type="condition" conceptid="4168796" conceptname="Muscle strain">strains</span> and <span class="product-label-link" type="condition" conceptid="30234" conceptname="Neck sprain">sprains</span>.</p>
</div>
<div class="Section" data-sectionCode="34071-1">
<a name="i4i_warnings_id_630871be-09d8-4b8b-9b96-5bb4f9bfe5de"></a><a name="section-5"></a><p></p>
<h1>Warnings</h1>
<p class="First">Use only as directed. If <span class="product-label-link" type="condition" conceptid="4329041" conceptname="Pain">pain</span> persists more than 10 days, or <span class="product-label-link" type="condition" conceptid="137193" conceptname="Erythema">redness</span> is present, or in conditions affecting children under 12 years of age, consult your physician immediately. Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes.</p>
<p>For external use only. Use only as directed. Do not apply to <span class="product-label-link" type="condition" conceptid="4029919" conceptname="Wound">wounds</span>, broken or irritated skin. Do not use with a heating pad. Do not bandage tightly.</p>
<p>If swallowed, induce <span class="product-label-link" type="condition" conceptid="441408" conceptname="Vomiting">vomiting</span> and contact a physician or poison control center immediately.</p>
</div>
<div class="Section" data-sectionCode="34068-7">
<a name="i4i_dosage_admin_id_b0148e3b-d670-4033-a88e-25f876a1cffa"></a><a name="section-6"></a><p></p>
<h1>Directions</h1>
<p class="First">Apply fast vanishing lotion with gentle massage to affected area not more than 3 to 4 times daily.</p>
</div>
<div class="Section" data-sectionCode="51727-6">
<a name="i4i_inactive_ingredients_id_342f5c00-09a0-4f72-9c8c-6d69edb43bd3"></a><a name="section-7"></a><p></p>
</div>
<div class="Section" data-sectionCode="51945-4">
<a name="i4i_Principal_display_panel_id_661c9819-0bef-4264-b96d-07613b513bff"></a><a name="section-8"></a><p></p>
<h1>Package/Label Principal Display Panel</h1>
<p class="First"><img alt="Banalg Hospital Strength" src="http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5b4c09e6-4228-47d5-b8f2-5959f8aede38&amp;name=5b4c09e6-4228-47d5-b8f2-5959f8aede38-01.jpg"></p>
</div>
</div>
<div class="DataElementsTables">
<table class="contentTablePetite" cellSpacing="0" cellPadding="3" width="100%"><tbody>
<tr><td class="contentTableTitle">
<strong>BANALG 		
					</strong><br><span class="contentTableReg">methyl salicylate lotion</span>
</td></tr>
<tr><td><table width="100%" cellpadding="5" cellspacing="0" class="formTablePetite">
<tr><td colspan="4" class="formHeadingTitle">Product Information</td></tr>
<tr class="formTableRowAlt">
<td class="formLabel">Product Type</td>
<td class="formItem">HUMAN OTC DRUG LABEL</td>
<td class="formLabel">Item Code (Source)</td>
<td class="formItem">NDC:21695-440(NDC:0456-0525)</td>
</tr>
<tr class="formTableRow">
<td width="30%" class="formLabel">Route of Administration</td>
<td class="formItem">TOPICAL</td>
<td width="30%" class="formLabel">DEA Schedule</td>
<td class="formItem">    
							</td>
</tr>
</table></td></tr>
<tr><td><table width="100%" cellpadding="3" cellspacing="0" class="formTablePetite">
<tr><td colspan="3" class="formHeadingTitle">Active Ingredient/Active Moiety</td></tr>
<tr>
<th class="formTitle" scope="col">Ingredient Name</th>
<th class="formTitle" scope="col">Basis of Strength</th>
<th class="formTitle" scope="col">Strength</th>
</tr>
<tr class="formTableRowAlt">
<td class="formItem">
<strong>METHYL SALICYLATE</strong> (METHYL SALICYLATE) </td>
<td class="formItem">METHYL SALICYLATE</td>
<td class="formItem">140 mg  in 1 g</td>
</tr>
<tr class="formTableRow">
<td class="formItem">
<strong>MENTHOL</strong> (MENTHOL) </td>
<td class="formItem">MENTHOL</td>
<td class="formItem">30 mg  in 1 g</td>
</tr>
</table></td></tr>
<tr><td><table width="100%" cellpadding="3" cellspacing="0" class="formTablePetite">
<tr><td colspan="2" class="formHeadingTitle">Inactive Ingredients</td></tr>
<tr>
<th class="formTitle" scope="col">Ingredient Name</th>
<th class="formTitle" scope="col">Strength</th>
</tr>
<tr class="formTableRowAlt">
<td class="formItem"><strong>1,3-DIMETHYLBUTYL SALICYLATE</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRow">
<td class="formItem"><strong>WATER</strong></td>
<td class="formItem"> </td>
</tr>
</table></td></tr>
<tr><td></td></tr>
<tr><td><table width="100%" cellpadding="3" cellspacing="0" class="formTablePetite">
<tr><td colspan="5" class="formHeadingTitle">Packaging</td></tr>
<tr>
<th scope="col" width="1" class="formTitle">#</th>
<th scope="col" class="formTitle">Item Code</th>
<th scope="col" class="formTitle">Package Description</th>
<th scope="col" class="formTitle">Marketing Start Date</th>
<th scope="col" class="formTitle">Marketing End Date</th>
</tr>
<tr class="formTableRowAlt">
<th scope="row" class="formItem">1</th>
<td class="formItem">NDC:21695-440-02</td>
<td class="formItem">60 g in 1 BOTTLE</td>
<td class="formItem"></td>
<td class="formItem"></td>
</tr>
</table></td></tr>
<tr><td></td></tr>
<tr><td class="normalizer"><table width="100%" cellpadding="3" cellspacing="0" class="formTableMorePetite">
<tr><td colspan="4" class="formHeadingReg"><span class="formHeadingTitle">Marketing Information</span></td></tr>
<tr>
<th scope="col" class="formTitle">Marketing Category</th>
<th scope="col" class="formTitle">Application Number or Monograph Citation</th>
<th scope="col" class="formTitle">Marketing Start Date</th>
<th scope="col" class="formTitle">Marketing End Date</th>
</tr>
<tr class="formTableRowAlt">
<td class="formItem">OTC monograph not final</td>
<td class="formItem">part348</td>
<td class="formItem">01/01/2007</td>
<td class="formItem"></td>
</tr>
</table></td></tr>
</tbody></table>
<table width="100%" cellpadding="3" cellspacing="0" class="formTableMorePetite"><tr><td colspan="4" class="formHeadingReg">
<span class="formHeadingTitle">Labeler - </span>Rebel Distributors Corp
							(118802834)
						</td></tr></table>
<table width="100%" cellpadding="3" cellspacing="0" class="formTableMorePetite">
<tr><td colspan="4" class="formHeadingReg"><span class="formHeadingTitle">Establishment</span></td></tr>
<tr>
<th scope="col" class="formTitle">Name</th>
<th scope="col" class="formTitle">Address</th>
<th scope="col" class="formTitle">ID/FEI</th>
<th scope="col" class="formTitle">Business Operations</th>
</tr>
<tr class="formTableRowAlt">
<td class="formItem">Rebel Distributors Corp</td>
<td class="formItem"></td>
<td class="formItem">118802834</td>
<td class="formItem">RELABEL, REPACK</td>
</tr>
</table>
</div>
<p><div class="EffectiveDate">Revised: 2/2011<div class="DocumentMetadata">
<div>
<a href="javascript:toggleMixin();">Document Id: </a>5b4c09e6-4228-47d5-b8f2-5959f8aede38</div>
<div>Set id: 5b4c09e6-4228-47d5-b8f2-5959f8aede38</div>
<div>Version: 1</div>
<div>Effective Time: 20110215</div>
</div>
</div> <div class="DistributorName">Rebel Distributors Corp</div></p>
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