<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="4cd5a719-3179-8975-e063-6294a90a9678"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>Swan 845.003/845AE
 <br/>
70% IPA, Wintergreen
</title>
   <effectiveTime value="20260312"/>
   <setId root="238029ed-e36d-4612-94d5-8cf96d60d115"/>
   <versionNumber value="14"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="088520668"/>
            <name>Vi-Jon, LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <id root="1.3.6.1.4.1.519.1" extension="119091520"/>
                  <name>Nice-Pak Products, LLC</name>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="119091514"/>
                        <name>Nice-Pak Products, LLC</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" displayName="manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <product>
                              <manufacturedProduct classCode="MANU">
                                 <manufacturedMaterialKind>
                                    <code code="0869-0845" codeSystem="2.16.840.1.113883.6.69"/>
                                 </manufacturedMaterialKind>
                              </manufacturedProduct>
                           </product>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="4cd5a45f-faba-b74d-e063-6394a90af823"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20260312"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="0869-0845" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>70% Rubbing</name>
                        <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Isopropyl Alcohol</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="H3R47K3TBD" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FD&amp;C BLUE NO. 1</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GLYCERIN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="LAV5U5022Y" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>METHYL SALICYLATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>WATER</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="I753WB2F1M" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FD&amp;C YELLOW NO. 5</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mL" value="70"/>
                              <denominator unit="mL" value="100"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="ND2M416302" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ISOPROPYL ALCOHOL</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="ND2M416302" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ISOPROPYL ALCOHOL</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="473" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="0869-0845-43" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                           </containerPackagedProduct>
                           <subjectOf>
                              <characteristic>
                                 <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                              </characteristic>
                           </subjectOf>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="19890715"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="M003" root="2.16.840.1.113883.3.9421"/>
                           <code code="C200263" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC Monograph Drug"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="19890715"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38304" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TOPICAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="L16d23e5c-3d51-49c3-b30b-1b332920e338">
               <id root="38e372b4-1966-e6ac-e063-6294a90af1c9"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active ingredient</title>
               <text>
                  <paragraph>Isopropyl alcohol 70%</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L900272d1-e334-403c-8910-c3997b2ea956">
               <id root="38e372b4-1967-e6ac-e063-6294a90af1c9"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>Purpose</title>
               <text>
                  <paragraph>First aid antiseptic</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="Lb343d860-b9a6-4f19-a88d-b70be36362f3">
               <id root="38e372b4-1968-e6ac-e063-6294a90af1c9"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Uses</title>
               <text>
                  <paragraph>first aid to help prevent the risk of infection in:</paragraph>
                  <list listType="unordered">
                     <item>minor cuts</item>
                     <item>scarapes</item>
                     <item>burns</item>
                  </list>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L83142f21-9e69-4bf8-98fc-0b299606a45b">
               <id root="38e372b4-1969-e6ac-e063-6294a90af1c9"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Warnings</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">For external use only.</content>If taken internally serious gastric disturbances will result.

 </paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L25cd011d-1321-4cc8-8855-036793e4039d">
               <id root="38e372b4-196a-e6ac-e063-6294a90af1c9"/>
               <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
               <title>Flammable</title>
               <text>
                  <paragraph>keep away from fire or flame, heat, spark, electrical</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L57fb799e-d4b7-4b08-8f37-2b1863e28c1c">
               <id root="38e372b4-196b-e6ac-e063-6294a90af1c9"/>
               <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
               <title>Ask a doctor before use</title>
               <text>
                  <paragraph>for deep or puncture wounds, animal bites or serious burns</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L17ed0a25-43f1-4c2d-850f-80460e2bffa0">
               <id root="38e372b4-196c-e6ac-e063-6294a90af1c9"/>
               <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
               <title>When using this product</title>
               <text>
                  <list listType="unordered">
                     <item>do not get into eyes</item>
                     <item>do not inhale</item>
                     <item>do not apply over large areas of the body</item>
                     <item>do not use longer than 1 week</item>
                  </list>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L39caae9e-8796-4fe4-8e3b-d5ca0a1aa158">
               <id root="38e372b4-196d-e6ac-e063-6294a90af1c9"/>
               <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
               <title>Stop use and ask a doctor if</title>
               <text>
                  <paragraph>condition persists or gets worse</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L60609fd0-17af-4929-a40c-b2c1b6a77f7b">
               <id root="38e372b4-196e-e6ac-e063-6294a90af1c9"/>
               <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
               <title>Keep out of reach of children.</title>
               <text>
                  <paragraph>If swallowed, get medical help or contact a Poison Control Center right away.</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L934e6209-280c-46a3-ad37-53168baa8d78">
               <id root="38e372b4-196f-e6ac-e063-6294a90af1c9"/>
               <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
               <title>Caution</title>
               <text>
                  <paragraph>Fumes can be acutuely irritating to skin, eyes and the respiratory system.  Do not apply to irritated skin or if excessive irritation develops.  Avoid getting into the eyes or on mucous membranes.  Avoid inhaling this product.</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L0bece6c5-f017-49ee-8044-d4b031dd37a2">
               <id root="38e372b4-1970-e6ac-e063-6294a90af1c9"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <list listType="unordered">
                     <item>clean the affected area</item>
                     <item>apply a small amount of the is product on the affected area 1 to 3 times daily</item>
                     <item>may be covered with a sterile bandage</item>
                     <item>if bandaged, let dry first</item>
                  </list>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="Ld9403093-0d76-49d5-a83c-f5440bb4da6d">
               <id root="38e372b4-1971-e6ac-e063-6294a90af1c9"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Other Information</title>
               <text>
                  <list listType="unordered">
                     <item>does not contain, nor is intended as a substitute for grain or ethyl alcohol</item>
                  </list>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="Lbf41f9f5-bc16-4aed-844f-c65b6f8a8f13">
               <id root="38e372b4-1972-e6ac-e063-6294a90af1c9"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive ingredient</title>
               <text>
                  <paragraph>blue 1, glycerin, methyl salicylate, water, yellow 5</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L96a1253b-3ac5-4b08-b366-3c6edae47bd7">
               <id root="38e372b4-1973-e6ac-e063-6294a90af1c9"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <title>Adverse reaction</title>
               <text>
                  <paragraph>Distributed by: Vi-Jon, LLC</paragraph>
                  <paragraph>One Swan Drive, Smyrna, TN 37167</paragraph>
                  <paragraph>Pat. D675, 101</paragraph>
               </text>
               <effectiveTime value="20250701"/>
            </section>
         </component>
         <component>
            <section ID="L6ed44945-e29e-4406-8307-0d57d75abd6b">
               <id root="38e372b4-1974-e6ac-e063-6294a90af1c9"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>principal display panel</title>
               <text>
                  <paragraph>NDC 0869-0845-43</paragraph>
                  <paragraph>swan
 
  <sup>﻿®</sup>
                  </paragraph>
                  <paragraph>70% Isopropyl Alcohol</paragraph>
                  <list listType="unordered">
                     <item>With Wintergreen and Glycerin</item>
                     <item>First Aid Antiseptic</item>
                  </list>
                  <paragraph>Square bottle uses less plastic than a similarly sized round bottle</paragraph>
                  <paragraph>Recyclable (if available in your area)</paragraph>
                  <paragraph>WARNING FLAMMALBE - Keep away from heat, spark, electrical, fire or flame</paragraph>
                  <paragraph>Use only in a well-ventilated area; fumes can be harmful</paragraph>
                  <paragraph>CAUTION: Do not point at self or others; product will squirt when squeezed.</paragraph>
                  <paragraph>16 FL OZ (1 PT) 473 mL</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lba9cb5d4-ceed-46d5-8d7c-6347bca6a9c7"/>
                     <renderMultiMedia referencedObject="L63cf2802-7755-4c81-a2e2-403ace088759"/>
                  </paragraph>
               </text>
               <effectiveTime value="20250701"/>
               <component>
                  <observationMedia ID="Lba9cb5d4-ceed-46d5-8d7c-6347bca6a9c7">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="mm01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L63cf2802-7755-4c81-a2e2-403ace088759">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="mm02.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>