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   <title>
      <content styleCode="bold">Dry-Clox<sup>®</sup>
      </content>
      <br/>
      <content styleCode="bold">(cloxacillin benzathine)</content>
      <br/>
      <content styleCode="bold">Intramammary Infusion</content>
      <br/>
      <content styleCode="bold">FOR USE IN DRY COW ONLY</content>
   </title>
   <effectiveTime value="20220518"/>
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      <time/>
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            <name>Boehringer Ingelheim Animal Health USA Inc.</name>
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                              <name>CLOXACILLIN BENZATHINE</name>
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               <text>
                  <paragraph>Approved by FDA under NADA # 055-058</paragraph>
               </text>
               <effectiveTime value="20210623"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Caution:</title>
               <text>
                  <paragraph>Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
               </text>
               <effectiveTime value="20140418"/>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>Description:</title>
               <text>
                  <paragraph>DRY-CLOX (cloxacillin benzathine) is a product which provides bactericidal activity against gram-positive bacteria in the dry cow. The active agent, cloxacillin benzathine, is a sparingly soluble salt of the semisynthetic penicillin, cloxacillin. Cloxacillin is a derivative of 6-aminopenicillanic acid, and therefore is chemically related to other penicillins. It has, however, the antibacterial properties described below, which distinguish it from certain other penicillins. </paragraph>
                  <paragraph>Each 10 mL disposable syringe contains cloxacillin benzathine equivalent to 500 mg of cloxacillin activity in a stable peanut oil gel. This product was manufactured by a non-sterilizing process.</paragraph>
               </text>
               <effectiveTime value="20210623"/>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Storage:</title>
               <text>
                  <paragraph>Do not store above 25°C (77°F). Do not freeze.</paragraph>
               </text>
               <effectiveTime value="20140418"/>
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               <title>Action:</title>
               <text>
                  <paragraph>In the non-lactating mammary gland, DRY-CLOX provides bactericidal levels of the active antibiotic, cloxacillin, for a prolonged period of time. This prolonged activity is due to the low solubility of the cloxacillin benzathine and to the slow-release oil-gel base. This prolonged contact between the antibiotic and the pathogenic organism enhances the probability of a bacteriological cure. </paragraph>
                  <paragraph>Cloxacillin is not destroyed by the enzyme, penicillinase, and therefore, is active against penicillin-resistant strains of <content styleCode="italics">Staphylococcus aureus</content>. It is also active against non-penicillinase-producing <content styleCode="italics">Staphylococcus aureus</content> as well as <content styleCode="italics">Streptococcus agalactiae</content>. </paragraph>
                  <paragraph>The class disc, Methicillin 5 mcg, should be used to estimate the <content styleCode="italics">in vitro</content> susceptibility of bacteria to cloxacillin. </paragraph>
               </text>
               <effectiveTime value="20210623"/>
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               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>Indications:</title>
               <text>
                  <paragraph>For the treatment of mastitis in dairy cows during the dry period.</paragraph>
                  <paragraph>DRY-CLOX has been shown by extensive clinical studies to be efficacious in the treatment of mastitis in dry cows, when caused by <content styleCode="italics">Streptococcus agalactiae</content> and <content styleCode="italics">Staphylococcus aureus</content> including penicillin-resistant strains. </paragraph>
                  <paragraph>Treatment of the dry cow with DRY-CLOX is indicated in any cow known to harbor any of these organisms in the udder at drying off, or which has had repeated attacks of mastitis during the previous lactation, or is affected with mastitis at drying off, if caused by susceptible organisms.</paragraph>
               </text>
               <effectiveTime value="20210623"/>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Dosage for Dry Cows:</title>
               <text>
                  <paragraph>Infuse the contents of one syringe (10 mL) into each quarter following the last milking. See Directions for Use. </paragraph>
               </text>
               <effectiveTime value="20140418"/>
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               <title>Directions for Use:</title>
               <text>
                  <paragraph>DRY-CLOX is for use in dry cows only. Administer immediately after the last milking. <content styleCode="bold">Use no later than 30 days prior to calving.</content>
                  </paragraph>
                  <paragraph>Completely milk out all four quarters. The udder and teats should be thoroughly washed with warm water containing a suitable dairy antiseptic and dried, preferably using individual paper towels. Carefully scrub the teat end and orifice with 70% alcohol, using a separate swab for each teat.<content styleCode="bold"> Allow to dry. </content>
                  </paragraph>
                  <paragraph>DRY-CLOX is packaged with the Opti-Sert<sup>® </sup>Protective Cap.</paragraph>
                  <paragraph>
                     <content styleCode="bold">For partial insertion: </content>Twist off upper portion of the Opti-Sert<sup>®</sup> Protective Cap to expose 3–4 mm of the syringe tip. </paragraph>
                  <paragraph>
                     <content styleCode="bold">For full insertion: </content>Remove protective cap to expose the full length of the syringe tip. </paragraph>
                  <paragraph>Insert syringe tip into the teat canal and expel the entire contents of syringe into the quarter. Withdraw the syringe and gently massage the quarter to distribute the medication. </paragraph>
                  <paragraph>Do not infuse contents of the mastitis syringe into the teat canal if the Opti-Sert<sup>®</sup> Protective Cap is broken or damaged. </paragraph>
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               <title>Precautions:</title>
               <text>
                  <paragraph>Because it is a derivative of 6-aminopenicillanic acid, DRY-CLOX has the potential for producing allergic reactions. Such reactions are rare; however, should they occur, the subject should be treated with antihistamines or pressor amines, such as epinephrine. </paragraph>
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               <title>Residue Warnings:</title>
               <text>
                  <paragraph>1. <content styleCode="bold">For use in dry cows only.</content>
                  </paragraph>
                  <paragraph>2. Not to be used within 30 days of calving.</paragraph>
                  <paragraph>3. Any animal infused with this product must not be slaughtered for food until 30 days after the latest infusion.</paragraph>
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               <effectiveTime value="20140418"/>
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               <title>How Supplied:</title>
               <text>
                  <paragraph>DRY-CLOX (cloxacillin benzathine) is supplied as 10 mL syringes containing 500 mg of cloxacillin activity per syringe. One display carton contains 12 syringes. One pail contains 144 syringes.</paragraph>
                  <paragraph>
                     <br/>NDC 0010-4720-02 - 12 syringes<br/>NDC 0010-4720-03 - 144 syringes<br/>
                  </paragraph>
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               <text>
                  <paragraph>Opti-Sert is a registered trademark of Zoetis W LLC - used under license.</paragraph>
                  <paragraph>DRY-CLOX is a registered trademark of Boehringer Ingelheim Animal Health USA Inc.</paragraph>
                  <paragraph>© 2020 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.</paragraph>
                  <paragraph>Made in Italy</paragraph>
                  <paragraph>
                     <content styleCode="bold">Marketed by:</content>
                     <br/>Boehringer Ingelheim Animal Health USA Inc.<br/>Duluth, GA 30096<br/>
                  </paragraph>
                  <paragraph>51744632</paragraph>
                  <paragraph>472001-04</paragraph>
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               <title>Principal Display Panel – Syringe Label </title>
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                  <paragraph>
                     <content styleCode="bold">Dry-Clox®</content>
                  </paragraph>
                  <paragraph>(cloxacillin benzathine)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Intramammary Infusion</content>
                  </paragraph>
                  <paragraph>Equivalent to 500 mg cloxacillin</paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution: </content>Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>FOR USE IN DRY COW ONLY</paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Contents: </content>10 mL</paragraph>
                  <paragraph>Approved by FDA under NADA # 055-058</paragraph>
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                     <text>A picture of the syringe label</text>
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               <title>Principal Display Panel – 12 x 10 mL display carton </title>
               <text>
                  <paragraph>NDC 0010-4720-02</paragraph>
                  <paragraph>
                     <content styleCode="bold">Dry-Clox®</content>
                  </paragraph>
                  <paragraph>(cloxacillin benzathine)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Intramammary Infusion</content>
                  </paragraph>
                  <paragraph>Equivalent to 500 mg cloxacillin</paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution:</content> Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>FOR USE IN DRY COW ONLY</paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Contents: </content>12 x 10 mL syringes</paragraph>
                  <paragraph>Approved by FDA under NADA # 055-058</paragraph>
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                     <text>A picture of the display carton</text>
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