Dry-Clox

Manufacturer
Boehringer Ingelheim Animal Health USA Inc.
Effective date
2022-05-18
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 02:41:25

Label at a glance#

ProductDry-Clox
Active ingredientCLOXACILLIN BENZATHINE
Label structure14 sections

Dosage and administration

DRY-CLOX is for use in dry cows only. Administer immediately after the last milking. Use no later than 30 days prior to calving. 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 tea...

Storage and handling

Do not store above 25°C (77°F). Do not freeze.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 055-058

Caution:

SPL UNCLASSIFIED SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

DESCRIPTION SECTION

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.

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.

Storage:

STORAGE AND HANDLING SECTION

Do not store above 25°C (77°F). Do not freeze.

Action:

MECHANISM OF ACTION SECTION

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.

Cloxacillin is not destroyed by the enzyme, penicillinase, and therefore, is active against penicillin-resistant strains of Staphylococcus aureus. It is also active against non-penicillinase-producing Staphylococcus aureus as well as Streptococcus agalactiae.

The class disc, Methicillin 5 mcg, should be used to estimate the in vitro susceptibility of bacteria to cloxacillin.

Indications:

VETERINARY INDICATIONS SECTION

For the treatment of mastitis in dairy cows during the dry period.

DRY-CLOX has been shown by extensive clinical studies to be efficacious in the treatment of mastitis in dry cows, when caused by Streptococcus agalactiae and Staphylococcus aureus including penicillin-resistant strains.

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.

Dosage for Dry Cows:

DOSAGE & ADMINISTRATION SECTION

Infuse the contents of one syringe (10 mL) into each quarter following the last milking. See Directions for Use.

Directions for Use:

DOSAGE & ADMINISTRATION SECTION

DRY-CLOX is for use in dry cows only. Administer immediately after the last milking. Use no later than 30 days prior to calving.

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. Allow to dry.

DRY-CLOX is packaged with the Opti-Sert® Protective Cap.

For partial insertion: Twist off upper portion of the Opti-Sert® Protective Cap to expose 3–4 mm of the syringe tip.

For full insertion: Remove protective cap to expose the full length of the syringe tip.

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.

Do not infuse contents of the mastitis syringe into the teat canal if the Opti-Sert® Protective Cap is broken or damaged.

Precautions:

PRECAUTIONS SECTION

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.

Residue Warnings:

RESIDUE WARNING SECTION

1. For use in dry cows only.

2. Not to be used within 30 days of calving.

3. Any animal infused with this product must not be slaughtered for food until 30 days after the latest infusion.

How Supplied:

HOW SUPPLIED SECTION

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.


NDC 0010-4720-02 - 12 syringes
NDC 0010-4720-03 - 144 syringes

SPL UNCLASSIFIED SECTION

Opti-Sert is a registered trademark of Zoetis W LLC - used under license.

DRY-CLOX is a registered trademark of Boehringer Ingelheim Animal Health USA Inc.

© 2020 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.

Made in Italy

Marketed by:
Boehringer Ingelheim Animal Health USA Inc.
Duluth, GA 30096

51744632

472001-04

Principal Display Panel – Syringe Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dry-Clox®

(cloxacillin benzathine)

Intramammary Infusion

Equivalent to 500 mg cloxacillin

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FOR USE IN DRY COW ONLY

Net Contents: 10 mL

Approved by FDA under NADA # 055-058

A picture of the syringe label
A picture of the syringe label

Principal Display Panel – 12 x 10 mL display carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0010-4720-02

Dry-Clox®

(cloxacillin benzathine)

Intramammary Infusion

Equivalent to 500 mg cloxacillin

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FOR USE IN DRY COW ONLY

Net Contents: 12 x 10 mL syringes

Approved by FDA under NADA # 055-058

A picture of the display carton
A picture of the display carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
104321910 ML cloxacillin 50 MG/ML Prefilled Syringe [Dry Clox]SBD11
104321510 ML cloxacillin 50 MG/ML Prefilled SyringeSCD11
104321910 ML Dry Clox 50 MG/ML Prefilled SyringeSY11
1043219Dry-Clox (as cloxacillin benzathine) 50 MG/ML 10 ML Prefilled SyringeSY11
1043219Dry-Clox 500 MG per 10 ML Prefilled SyringeSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0010-4720-01Dry-Clox10 mL in 1 SYRINGEGEL1011
0010-4720-02Dry-Clox12 in 1 CARTONGEL1211
0010-4720-03Dry-Clox144 in 1 PAILGEL14411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0010-4720DRY-CLOX (CLOXACILLIN BENZATHINE) GEL [BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.]113 package rows20220519_6fbf05bc-2be7-4a26-9ed4-107b4b4d8a5b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOXACILLIN BENZATHINEACTIVE INGREDIENTAC79L7PV2G6
CLOXACILLINACTIVE MOIETYO6X5QGC2VB6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0010-47200010-4720-01, 0010-4720-02, 0010-4720-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.