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        <name>Droptics LLC</name>
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                <name>Droptics Dry Eye Relief</name>
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                    <name>Carboxymethylcellulose Sodium,Glycerin,Polysorbate 80</name>
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                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="7FLD91C86K" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>EDETATE DISODIUM</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="R57ZHV85D4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>BORIC ACID</name>
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                    <name>PYRIDOXINE HYDROCHLORIDE</name>
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                    <name>TAURINE</name>
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                <ingredient classCode="IACT">
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                    <code code="9E8X80D2L0" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>.ALPHA.-TOCOPHEROL ACETATE</name>
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                    <name>SODIUM HYDROXIDE</name>
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                <ingredient classCode="IACT">
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                    <code code="QTT17582CB" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>HYDROCHLORIC ACID</name>
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                    <name>CARBOXYMETHYLCELLULOSE SODIUM</name>
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                        <code code="05JZI7B19X" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>CARBOXYMETHYLCELLULOSE</name>
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                    <numerator unit="g" value="1"/>
                    <denominator unit="mL" value="100"/>
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                  <ingredientSubstance>
                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>GLYCERIN</name>
                      </activeMoiety>
                    </activeMoiety>
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                </ingredient>
                <ingredient classCode="ACTIB">
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                    <numerator unit="g" value="0.5"/>
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                  <ingredientSubstance>
                    <code code="6OZP39ZG8H" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYSORBATE 80</name>
                    <activeMoiety>
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                        <code code="6OZP39ZG8H" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>PEG-20 SORBITAN OLEATE</name>
                      </activeMoiety>
                    </activeMoiety>
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                </ingredient>
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                    <denominator value="1"/>
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                        <numerator unit="1" value="1"/>
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                            <low value="20250201"/>
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                  <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"/>
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                    <low value="20250201"/>
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              </subjectOf>
              <consumedIn>
                <substanceAdministration>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="italics">Active Ingredients</content>
          </title>
          <text>
            <paragraph>Carboxymethylcellulose sodium 0.5% 
  <br/>  Glycerin 1% 
  <br/>  Polysorbate 80 0.5%
 </paragraph>
          </text>
          <effectiveTime value="20260202"/>
        </section>
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          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>
            <content styleCode="italics">Purpose</content>
          </title>
          <text>
            <paragraph>Lubricant</paragraph>
          </text>
          <effectiveTime value="20251231"/>
        </section>
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          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>
            <content styleCode="italics">Uses</content>
          </title>
          <text>
            <paragraph>For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun 
  <br/>  For use as a protectant against further irritation
 </paragraph>
          </text>
          <effectiveTime value="20251231"/>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>
            <content styleCode="italics">Warnings</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">For external use only</content>
              <br/>  Do not use if solution changes color 
  <br/>
              <content styleCode="bold">When using this product</content>
              <br/>  • Do not touch tip of the container to any surface to avoid contamination 
  <br/>  • Replace cap after each use 
  <br/>
              <content styleCode="bold">Stop use and ask a doctor if</content>
              <br/>  • If you feel eye pain 
  <br/>  • Changes in vision occur 
  <br/>  • Redness or irritation of the eye lasts 
  <br/>  • Condition worsens or lasts more than 72 hours 
  <br/>
              <content styleCode="bold">Keep out of reach of children</content>
              <br/>  • If swallowed, get medical help or contact a Poison Control Center right away

 </paragraph>
            <paragraph/>
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          <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
          <title/>
          <text>
            <paragraph/>
          </text>
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>
            <content styleCode="italics">Directions</content>
          </title>
          <text>
            <paragraph>Put 1 or 2 drops in the affected eye(s) as needed.</paragraph>
            <list listType="unordered">
              <item>Tightly screw on cap to seal after use.</item>
            </list>
          </text>
          <effectiveTime value="20251231"/>
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          <title>
            <content styleCode="italics">Other information</content>
          </title>
          <text>
            <paragraph>Store at 20 - 25°C (68 -77°F)</paragraph>
          </text>
          <effectiveTime value="20250311"/>
        </section>
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          <title>
            <content styleCode="italics">Inactive ingredients</content>
          </title>
          <text>
            <paragraph>L-arginine (amino acid), boric acid, cyanocobalamin (Vitamin B12), edetate disodium, potassium chloride, purified water, pyridoxine hydrochloride (Vitamin B6), sodium chloride, sodium citrate, stabilized oxychloro complex, taurine (amino acid), tocopherol acetate (Vitamin E), trehalose, sodium hydroxide and/or hydrochloric acid (to adjust pH)</paragraph>
          </text>
          <effectiveTime value="20260202"/>
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          <title>Product label</title>
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