<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="a9c86aef-99ce-4838-b95b-b9741e017c34"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>Niravi 24 Hours Lidocaine 4% Patch</title>
   <effectiveTime value="20210708"/>
   <setId root="8b1c336b-bfcd-423b-bab3-464d119f5635"/>
   <versionNumber value="3"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="079365856"/>
            <name>Sparsha Pharma USA, Inc.</name>
            <assignedEntity>
               <assignedOrganization>
                  <id extension="079365856" root="1.3.6.1.4.1.519.1"/>
                  <name>Sparsha Pharma USA, Inc.</name>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="079365856"/>
                        <name>Sparsha Pharma USA, Inc.</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="73638-901" 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="25d6de4e-11cd-4665-afe9-462ccb4f4042"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20210706"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="73638-901" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Niravi 24 Hours Lidocaine 4 % Patch</name>
                        <formCode code="C42968" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="PATCH"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Lidocaine</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="4" unit="g"/>
                              <denominator value="100" unit="g"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="98PI200987" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>LIDOCAINE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="98PI200987" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>LIDOCAINE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="T5L8T28FGP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MINERAL OIL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="39EYQ1W9RB" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>HYDROGENATED C6-20 POLYOLEFIN (100 CST)</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="1SSZ6HXE7P" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85)</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="1" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <formCode code="C82332" displayName="PATCH" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="6" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="73638-901-01" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                                 <subjectOf>
                                    <marketingAct>
                                       <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                       <statusCode code="active"/>
                                       <effectiveTime>
                                          <low value="20210630"/>
                                       </effectiveTime>
                                    </marketingAct>
                                 </subjectOf>
                              </asContent>
                           </containerPackagedProduct>
                           <subjectOf>
                              <characteristic classCode="OBS">
                                 <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C112160" displayName="Type 0: Not a Combination Product" codeSystem="2.16.840.1.113883.3.26.1.1" xsi:type="CE"/>
                              </characteristic>
                           </subjectOf>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20210630"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <id extension="part348" root="2.16.840.1.113883.3.149"/>
                           <code code="C73604" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC monograph not final"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </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="Ld04d64ef-2408-47cf-8f8e-2484c568952b">
               <id root="a08d7334-b9de-4023-ac80-9c4e9c1dca40"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active Ingredient</title>
               <text>
                  <paragraph>Lidocaine 4%</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="L602f63e2-8f64-47ed-b19c-0b27173e39da">
               <id root="7c054bbd-0bdd-4068-b286-6ed6049b4d69"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>Purpose</title>
               <text>
                  <paragraph>Topical anesthetic</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="Lfd3e2115-a498-4124-a103-12a0bf231179">
               <id root="3d64be82-20b5-4ee2-b5cd-0da5f56bacdc"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Use</title>
               <text>
                  <paragraph>For the temporary relief of minor pain.</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="Lcaf66ddd-8cc3-4e18-abc2-e0c39be31dd6">
               <id root="b62e2fb1-e24f-415d-9d09-69b3b6a72da6"/>
               <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>
                  </paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="Lfd254141-b8de-4ff4-816d-3bb9bd695de0">
               <id root="5c3850ea-3a65-4dd5-9716-7720ca66c778"/>
               <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
               <title>Do not use</title>
               <text>
                  <paragraph>• If you are allergic to any active or inactive ingredients of this product<br/>• On wounds or damaged, irritated or sensitive skin<br/>• With any other topical anesthetic<br/>• For more than one week without consulting a doctor<br/>• With a heating pad<br/>• If pouch is damaged or opened.</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="Le7939f02-d5f2-4ac5-9876-45cd8f3be4c8">
               <id root="ddaab098-ea29-4fef-a72d-1dfb18ebae2f"/>
               <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
               <title>When using this product</title>
               <text>
                  <paragraph>• Do not allow contact with the eyes<br/>• Use only as directed<br/>• Read and follow all directions and warnings on this package<br/>• Do not bandage tightly or apply local heat to the area of use<br/>• Do not reuse patch<br/>• Keep this product away from pets and children. Used patches still contains the drug product that can produce serious adverse effect if child or pet chews or ingest this patch.</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="Lf95644d8-5ed4-44c2-83a3-84c6ce989644">
               <id root="c3b91966-0b11-47a9-9bd4-3bbe6c2bf81c"/>
               <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 worsens<br/>• Symptoms persist for more than seven days or clear up and occur again within a few days<br/>• Localized skin reactions occur such as rash, pain, itching, redness, irritation, swelling or blistering where the product was applied.</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="La670ec18-f41c-4671-8ada-fed96eae5838">
               <id root="e39347ef-605a-44a4-abc5-1c9058f65fce"/>
               <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">If pregnant or breast-feeding,</content> ask a health professional before use.</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="Lcd426d4b-3b9b-4596-8090-e2473cab2a37">
               <id root="255a7e6a-eadb-4109-894b-29aea873c77c"/>
               <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Keep out of reach of children and pets.</content> If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="L05a21922-ed79-4de2-9cf5-d7c036d3067c">
               <id root="c703d0f5-89f5-44ce-abe4-f9a7b17b4112"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <paragraph>Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Do not expose area to heat.</paragraph>
                  <paragraph>Children under 12 years of age: Consult a doctor.</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="L6ee0448f-8981-4807-9a1a-baaad6b26676">
               <id root="487ae8d6-c557-42b5-bf7c-74f545dae5be"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive Ingredients</title>
               <text>
                  <paragraph>Alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="L32778fab-b54c-4a9d-87fb-f7d0965648bd">
               <id root="2a7cfc8d-6ee3-49b1-a412-66792865ad9c"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Other information</title>
               <text>
                  <paragraph>.Store in a clean, dry place away from direct sunlight. Store in original unopened pouch. protected from moisture.</paragraph>
               </text>
               <effectiveTime value="20210630"/>
            </section>
         </component>
         <component>
            <section ID="Lc866f9c4-c68a-480a-aa67-bb9bd17530d0">
               <id root="6f4d8440-ba68-4481-9f5c-bee8b9665058"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Questions ?</title>
               <text>
                  <paragraph>Customer Care Helpline 844-348-5423 Monday- Friday 8:30 a.m – 4:30 p.m PST</paragraph>
               </text>
               <effectiveTime value="20210708"/>
            </section>
         </component>
         <component>
            <section ID="Lbba0b436-a397-4adc-9cf1-18e6c6fed888">
               <id root="876a8931-b375-4874-939b-a13157e3a2fe"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PACKAGE LABEL</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Carton Label NDC 73638-901-01</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <renderMultiMedia referencedObject="Lbee343b4-5a18-4578-b6d6-1d19a27ad936"/>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Pouch Label</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <renderMultiMedia referencedObject="L05e5961c-f7c3-48de-84ce-d61fdff023db"/>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20210708"/>
               <component>
                  <observationMedia ID="Lbee343b4-5a18-4578-b6d6-1d19a27ad936">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="carton_image.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L05e5961c-f7c3-48de-84ce-d61fdff023db">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="pouch label.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>