Label: MULTIMIN 90- zinc oxide, manganese carbonate, sodium selenite, copper carbonate injection, solution

  • NDC Code(s): 49920-006-01, 49920-006-05
  • Packager: Multimin North America, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated September 12, 2024

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  • SPL UNCLASSIFIED SECTION

    MULTIMIN® 90

    (zinc, copper, manganese, and selenium injection)

    A sterile solution for subcutaneous injection containing 60 mg/mL zinc, 15 mg/mL copper, 10 mg/mL manganese, and 5 mg/mL selenium.


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

  • DESCRIPTION

    An injectable blue aqueous sterile solution for subcutaneous injection.

  • SPL UNCLASSIFIED SECTION

    Active Ingredients:
    Zinc                      60 mg/mL (as zinc oxide)
    Copper                 15 mg/mL (as copper carbonate)
    Manganese          10 mg/mL (as manganese carbonate)
    Selenium               5 mg/mL (as sodium selenite)

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Edetic acid                   399.74 mg/mL
    Sodium hydroxide        106.9 mg/mL
    Benzyl alcohol              10.4 mg/mL (as preservative)

  • INDICATIONS FOR USE

    To provide a supplemental source of zinc, copper, manganese, and selenium in cattle. Not for use in pregnant cows and heifers during their first trimester because reproductive safety testing has not been done in these animals. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety has not been established.

  • DOSAGE AND ADMINISTRATION

    Determine accurate body weights prior to treatment. Administer subcutaneously under the loose skin of the middle of the side of the neck per the following dosages depending on age and bodyweight of the cattle:


    Cattle up to 1 year, 1 mL/100 lb bodyweight
    Cattle from 1-2 years, 1 mL/150 lb bodyweight
    Cattle over 2 years, 1 mL/200 lb bodyweight


    To be administered as a single dose.

    MULTIMIN® 90 is to be given subcutaneously (under the skin) ONLY.

    cow image

    The maximum volume per injection site is 7 mL. Use standard aseptic procedures during administration to reduce the risk of injection site abscesses or lesions. Ensure there are at least 4 inches between injection sites for MULTIMIN® 90 and other injection sites.


    MULTIMIN® 90 is intended as a single dose product. Allow a minimum of 30 days before considering repeat dosing. Additional zinc, copper, manganese, or selenium products should not be administered at the same time.


    Use within 28 days of first puncture of the vial and puncture a maximum of 15 times. If more than 15 punctures are anticipated, the use of multi-dosing equipment is recommended. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any product remaining in the vial immediately after use.

  • CONTRAINDICATIONS

    Do not use MULTIMIN® 90 (zinc, copper,
    manganese, and selenium injection)
    concurrently with other injectable selenium
    and copper products.
    Do not use MULTIMIN® 90 concurrently with
    selenium or copper boluses.

  • WARNINGS AND PRECAUTIONS

    Withdrawal Periods
    Cattle must not be slaughtered for human food consumption within 14 days of the last treatment. No milk discard time is required when used according to labeling.

  • User Safety Warnings

    Not for use in humans. Keep out of reach of children. Do not allow children access to used or empty syringes. Wash hands after use.


    This product is highly concentrated in zinc, copper, manganese, and selenium. Due to a potential risk of zinc, copper, manganese, and selenium toxicity, care should be taken when handling the product to avoid accidental self-injection. Symptoms of exposure to zinc, copper, manganese, and selenium include aches, chills, nausea, vomiting, diarrhea, tachycardia, epigastric pain, tremors, and irritability.


    In case of accidental self-injection or ingestion, SEEK IMMEDIATE MEDICAL ATTENTION and take the vial with you.


    To obtain a Safety Data Sheet, contact Multimin North America, Inc. at 970-372-2302.

  • Animal Safety Warnings and Precautions

    Selenium and copper are toxic if administered in excess. MULTIMIN® 90 may cause clinical signs associated with copper toxicity or selenium toxicity, including death, if overdosed or used in conjunction with excessive dietary levels of copper and selenium or other selenium or copper products. Additional zinc, copper, manganese, or selenium products should not be administered at the same time. Do not use concurrently with other injectable selenium and copper products. Do not use concurrently with selenium or copper boluses.


    MULTIMIN® 90 may cause injection site swelling that appears on the day of injection and resolves by 2 days later. MULTIMIN® 90 may cause induration at the injection site that appears the day of injection and may persist for at least 14 days post-injection. These reactions may result in trim loss of edible tissue at slaughter.


    Do not use in cases of known hypersensitivity to the active ingredients or to any of the excipients. Do not use in emaciated cattle with a body condition score of 1 on a 5-point scale in dairy or 1-3 on a 9-point scale in beef.


    Do not use during the first trimester of pregnancy because safety has not been evaluated. Do not use in pre-ruminant calves because safety has not been evaluated.

  • ADVERSE REACTIONS

    Accidental overdose of copper or selenium through misdosing or the use of multiple sources, including the use of injectable products in addition to high dietary levels, can result in adverse events, including death, depression, weakness, ataxia, salivation, and drooling.

  • CONTACT INFORMATION

    Contact Multimin North America, Inc. at 970-372-2302 or http://www.axiota.com. To report suspected adverse drug experiences, contact Multimin North America, Inc. at 970-372-2302. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS (1-888-332-8387) or http://www.fda.gov/reportanimalae

  • CLINICAL PHARMACOLOGY

    As essential minerals, zinc, copper, manganese, and selenium, contribute to homeostasis by participating as cofactors of a wide range of enzymes in multiple biochemical processes in the body. In a laboratory margin of safety study in 32 growing cattle less than 1 year of age, after daily subcutaneous administration of MULTIMIN® 90 (zinc, copper, manganese, and selenium injection) for 3 days (see Target Animal Safety section), a dose-related increase in plasma concentrations of zinc, copper, manganese, and selenium was observed for treated animals when compared with untreated controls.

  • TARGET ANIMAL SAFETY

    MULTIMIN® 90 or saline was injected subcutaneously over 3 consecutive days to 32 English and/or Continental pure or mixed beef breed cattle (16 non-pregnant females and 16 intact males, 4 animals per sex per treatment group) ranging in weight from 289-387 kg and less than 10 months of age. Treatment groups were 1x [1 mL MULTIMIN® 90/100 lb (45 kg) body weight (BW)], 3x [3 mL MULTIMIN® 90/100 lb (45 kg) BW], 5x [5 mL MULTIMIN® 90/100 lb (45 kg) BW], or control group [5 mL saline/100 lb (45 kg) BW]. All animals were euthanized and necropsied 1 to 2 days after the last treatment. The only treatment-associated findings from the 1x dose group included injection site swelling and a minor, clinically insignificant, dose and time dependent decrease in cholesterol. The treatment-associated findings from the 3x dose group were injection site swelling, a decrease in feed consumption, and a decrease in cholesterol. In the 5x dose group, treatment-associated findings included injection site swelling, a decrease in feed consumption, a decrease in cholesterol, an increase in creatinine kinase, a decrease in calcium, and signs of acute copper toxicity (2 out of 8 animals), including sudden death, depression, weakness, ataxia, salivation, and drooling. Animals in the 5x dose group also had hepatic centrilobular necrosis on necropsy and an increase in serum chemistries associated with liver damage.


    Sixteen animals were each injected with MULTIMIN® 90 and saline subcutaneously on opposite sides of the neck. Eleven animals were administered 1 mL/50 kg body weight and the other 5 animals received the maximum dose per injection site of 7 mL. Injection of MULTIMIN® 90 resulted in pain upon injection (1 of 16 animals); injection site swelling that appeared on the day of injection and resolved 2 days later; and induration that appeared on the day of injection and persisted for at least 14 days. Subcutaneous injection of MULTIMIN® 90 in cattle can cause a local tissue reaction. These reactions may result in trim loss of edible tissue at slaughter.

  • EFFECTIVENESS

    To provide a supplemental source of zinc, copper, manganese, and selenium was demonstrated in a single multisite study. A total of 90 Holstein replacement dairy heifers, approximately 9 months of age, were administered either a single subcutaneous injection of MULTIMIN® 90 or saline at a dose of 1 mL/100 lb (45 kg) BW on Day 0. Blood samples were obtained for plasma zinc, copper, manganese, and selenium analysis within 1 to 2 hours prior to dosing, and 0.5 hours (± 10 minutes), 1 hour (± 10 minutes), 3 hours (± 15 minutes), 6 hours (± 15 minutes), and 8 hours (± 15 minutes) post-treatment. Treatment was considered successful if the partial area under the plasma concentration curve from dosing to 8 hours (AUC0-8) of zinc, copper, manganese, and selenium was significantly different and higher in the MULTIMIN® 90 treated group versus the saline treated group. For all four minerals the AUC0-8 was different and higher in the MULTIMIN® 90 treated group versus the saline treated group. The mean AUC0-8 for zinc plasma concentration was significantly different and higher (P-value=0.0031) in the MULTIMIN® 90 treated group (16.36 hour*mg/L) compared to the saline treated group (7.74 hour*mg/L). The mean AUC0-8 for copper plasma concentration was significantly different and higher (P-value=0.0041) in the MULTIMIN® 90 treated group (8.34 hour*mg/L) compared to the saline treated group (7.05 hour*mg/L). The mean AUC0-8 for manganese plasma concentration was significantly different and higher (P-value=0.0023) in the MULTIMIN® 90 treated group (253.79 hour*μg/L) compared to the saline treated group (10.89 hour*μg/L). The mean AUC0-8 for selenium plasma concentration was significantly different and higher (P-value=0.0042) in the MULTIMIN® 90 treated group (2734.03 hour*μg/L) compared to the saline treated group (790.25 hour*μg/L).

  • HOW SUPPLIED

    MULTIMIN® 90 is available in the following package sizes:
    100 mL vial
    500 mL vial


    NDC# 49920-006-01
    NDC# 49920-006-05

  • STORAGE, HANDLING, AND DISPOSAL

    Store between 15°C and 30°C (59°F and 86°F).


    Approved by FDA under NADA # 141-582

  • NAME AND PLACE OF BUSINESS

    Manufactured for: Multimin North America, Inc.,
    2809 East Harmony Rd. Suite 190, Fort Collins, CO 80528
    Manufactured by: Nova-Tech, Inc.,
    4705 Gold Core Rd., Grand Island, NE, 68801

    U.S. Patent: www.axiota.com/patent


    Made in Ireland


    REVISION DATE
    December 2023

  • Package Label Principle Display Panel

    MULTIMIN® 90

    (zinc, copper, manganese, and selenium injection)

    A sterile solution for
    subcutaneous injection
    containing 60 mg/mL zinc,
    15 mg/mL copper, 10 mg/mL
    manganese, and
    5 mg/mL selenium.

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

    Withdrawal periods

    Cattle must not be slaughtered for human food

    consumption within 14 days of the last treatment.

    No milk discard time is required when used according to labeling.

    STORAGE, HANDLING, AND DISPOSAL
    Store between 15ºC and 30ºC
    (59ºF and 86ºF)

    Manufactured for: Multimin North
    America, Inc.
    Fort Collins, CO 80528

    Approved by FDA under NADA # 141-582

    NET CONTENTS: 100mL

    INDICATIONS FOR USE

    To provide a supplemental source of
    zinc, copper, manganese, and
    selenium in cattle. Not for use in
    pregnant cows and heifers during
    their first trimester because
    reproductive safety testing has not
    been done in these animals. Do not
    use in beef calves less than 2 months
    of age, dairy calves, and veal calves
    because safety has not been
    established.
    Before using this drug, read package
    insert for full prescribing information.
    Refer to inside label for dosage and
    administration information.

    Lot No.:          Exp. Date:

    CONTRAINDICATIONS
    Do not use MULTIMIN® 90 (zinc, copper,
    manganese, and selenium injection) concurrently
    with other injectable selenium and copper products.
    Do not use MULTIMIN® 90 concurrently with
    selenium or copper boluses.

    User Safety Warnings
    Not for use in humans. Keep out of reach of
    children. Do not allow children access to used or
    empty syringes. Wash hands after use.
    This product is highly concentrated in zinc, copper,
    manganese, and selenium. Due to a potential risk of
    zinc, copper, manganese, and selenium toxicity, care
    should be taken when handling the product to
    avoid accidental self-injection. Symptoms of
    exposure to zinc, copper, manganese, and selenium
    include aches, chills, nausea, vomiting, diarrhea,
    tachycardia, epigastric pain, tremors, and irritability.

    In case of accidental self-injection or ingestion, SEEK
    IMMEDIATE MEDICAL ATTENTION and take the vial
    with you.
    To obtain a Safety Data Sheet, contact Multimin
    North America, Inc. at 970-372-2302.

    Animal Safety Warnings and Precautions
    Selenium and copper are toxic if administered in
    excess. MULTIMIN® 90 may cause clinical signs
    associated with copper toxicity or selenium toxicity,
    including death, if overdosed or used in conjunction
    with excessive dietary levels of copper and selenium or
    other selenium or copper products. Additional zinc,
    copper, manganese, or selenium products should not
    be administered at the same time. Do not use
    concurrently with other injectable selenium and
    copper products. Do not use concurrently with
    selenium or copper boluses.

    MULTIMIN® 90 may cause injection site swelling that
    appears on the day of injection and resolves by 2
    days later. MULTIMIN® 90 may cause induration at
    the injection site that appears the day of injection
    and may persist for at least 14 days post-injection.
    These reactions may result in trim loss of edible
    tissue at slaughter.


    Do not use in cases of known hypersensitivity to the
    active ingredients or to any of the excipients. Do not
    use in emaciated cattle with a body condition score
    of 1 on a 5-point scale in dairy or 1-3 on a 9-point
    scale in beef.


    Do not use during the first trimester of pregnancy
    because safety has not been evaluated. Do not use
    in pre-ruminant calves because safety has not been
    evaluated.

    ACTIVE INGREDIENTS
    Zinc..........................................60 mg/mL (as zinc oxide)
    Copper.........................15 mg/mL (as copper carbonate)
    Manganese............10 mg/mL (as manganese carbonate)
    Selenium...........................5 mg/mL (as sodium selenite)


    INACTIVE INGREDIENTS
    Edetic acid................................................399.74 mg/mL
    Sodium hydroxide......................................106.9 mg/mL
    Benzyl alcohol...................10.4 mg/mL (as preservative)


    DOSAGE AND ADMINISTRATION
    Determine accurate body weights prior to treatment.
    Administer subcutaneously under the loose skin of the
    middle of the side of the neck per the following dosages
    depending on age and bodyweight of the cattle:
    Cattle up to 1 year, 1 mL/100 lb bodyweight
    Cattle from 1-2 years, 1 mL/150 lb bodyweight
    Cattle over 2 years, 1 mL/200 lb bodyweight

    To be administered as a single dose.

    MULTIMIN® 90 is to be
    given subcutaneously
    (under the skin) ONLY.

    The maximum volume per injection site is 7 mL. Use standard aseptic procedures
    during administration to reduce the risk of injection site abscesses or lesions. Ensure
    there are at least 4 inches between injection sites for MULTIMIN® 90 and other
    injection sites.

    MULTIMIN® 90 is intended as a single dose product. Allow a minimum of 30 days
    before considering repeat dosing. Additional zinc, copper, manganese, or selenium
    products should not be administered at the same time.


    Use within 28 days of first puncture of the vial and puncture a maximum of 15 times. If
    more than 15 punctures are anticipated, the use of multi-dosing equipment is
    recommended. When using a draw-off spike or needle with bore diameter larger than
    16 gauge, discard any product remaining in the vial immediately after use.

    100 ml label

  • Package Label Principle Display Panel

    MULTIMIN® 90

    (zinc, copper, manganese, and selenium injection)

    A sterile solution for
    subcutaneous injection
    containing 60 mg/mL zinc,
    15 mg/mL copper, 10 mg/mL
    manganese, and
    5 mg/mL selenium.

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

    Withdrawal periods

    Cattle must not be slaughtered for human food

    consumption within 14 days of the last treatment.

    No milk discard time is required when used according to labeling.

    STORAGE, HANDLING, AND DISPOSAL
    Store between 15ºC and 30ºC
    (59ºF and 86ºF)

    Manufactured for: Multimin North
    America, Inc.
    Fort Collins, CO 80528

    Approved by FDA under NADA # 141-582

    NET CONTENTS: 500mL

    INDICATIONS FOR USE

    To provide a supplemental source of
    zinc, copper, manganese, and
    selenium in cattle. Not for use in
    pregnant cows and heifers during
    their first trimester because
    reproductive safety testing has not
    been done in these animals. Do not
    use in beef calves less than 2 months
    of age, dairy calves, and veal calves
    because safety has not been
    established.
    Before using this drug, read package
    insert for full prescribing information.
    Refer to inside label for dosage and
    administration information.

    Lot No.:             Exp. Date:

    CONTRAINDICATIONS
    Do not use MULTIMIN® 90 (zinc, copper,
    manganese, and selenium injection) concurrently
    with other injectable selenium and copper products.
    Do not use MULTIMIN® 90 concurrently with
    selenium or copper boluses.

    User Safety Warnings
    Not for use in humans. Keep out of reach of
    children. Do not allow children access to used or
    empty syringes. Wash hands after use.
    This product is highly concentrated in zinc, copper,
    manganese, and selenium. Due to a potential risk of
    zinc, copper, manganese, and selenium toxicity, care
    should be taken when handling the product to
    avoid accidental self-injection. Symptoms of
    exposure to zinc, copper, manganese, and selenium
    include aches, chills, nausea, vomiting, diarrhea,
    tachycardia, epigastric pain, tremors, and irritability.

    In case of accidental self-injection or ingestion, SEEK
    IMMEDIATE MEDICAL ATTENTION and take the vial
    with you.


    To obtain a Safety Data Sheet, contact Multimin
    North America, Inc. at 970-372-2302.

    Animal Safety Warnings and Precautions
    Selenium and copper are toxic if administered in
    excess. MULTIMIN® 90 may cause clinical signs
    associated with copper toxicity or selenium toxicity,
    including death, if overdosed or used in conjunction
    with excessive dietary levels of copper and selenium or
    other selenium or copper products. Additional zinc,
    copper, manganese, or selenium products should not
    be administered at the same time. Do not use
    concurrently with other injectable selenium and
    copper products. Do not use concurrently with
    selenium or copper boluses.

    MULTIMIN® 90 may cause injection site swelling that
    appears on the day of injection and resolves by 2
    days later. MULTIMIN® 90 may cause induration at
    the injection site that appears the day of injection
    and may persist for at least 14 days post-injection.
    These reactions may result in trim loss of edible
    tissue at slaughter.

    Do not use in cases of known hypersensitivity to the
    active ingredients or to any of the excipients. Do not
    use in emaciated cattle with a body condition score
    of 1 on a 5-point scale in dairy or 1-3 on a 9-point
    scale in beef.

    Do not use during the first trimester of pregnancy
    because safety has not been evaluated. Do not use
    in pre-ruminant calves because safety has not been
    evaluated.

    ACTIVE INGREDIENTS
    Zinc..........................................60 mg/mL (as zinc oxide)
    Copper.........................15 mg/mL (as copper carbonate)
    Manganese............10 mg/mL (as manganese carbonate)
    Selenium...........................5 mg/mL (as sodium selenite)

    INACTIVE INGREDIENTS
    Edetic acid................................................399.74 mg/mL
    Sodium hydroxide......................................106.9 mg/mL
    Benzyl alcohol...................10.4 mg/mL (as preservative)

    DOSAGE AND ADMINISTRATION
    Determine accurate body weights prior to treatment.
    Administer subcutaneously under the loose skin of the
    middle of the side of the neck per the following dosages
    depending on age and bodyweight of the cattle:


    Cattle up to 1 year, 1 mL/100 lb bodyweight
    Cattle from 1-2 years, 1 mL/150 lb bodyweight
    Cattle over 2 years, 1 mL/200 lb bodyweight

    To be administered as a single dose.

    MULTIMIN® 90 is to be
    given subcutaneously
    (under the skin) ONLY.

    The maximum volume per injection site is 7 mL. Use standard aseptic procedures
    during administration to reduce the risk of injection site abscesses or lesions. Ensure
    there are at least 4 inches between injection sites for MULTIMIN® 90 and other
    injection sites.

    MULTIMIN® 90 is intended as a single dose product. Allow a minimum of 30 days
    before considering repeat dosing. Additional zinc, copper, manganese, or selenium
    products should not be administered at the same time.

    Use within 28 days of first puncture of the vial and puncture a maximum of 15 times. If
    more than 15 punctures are anticipated, the use of multi-dosing equipment is
    recommended. When using a draw-off spike or needle with bore diameter larger than
    16 gauge, discard any product remaining in the vial immediately after use.

    500 ml label

  • INGREDIENTS AND APPEARANCE
    MULTIMIN 90 
    zinc oxide, manganese carbonate, sodium selenite, copper carbonate injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:49920-006
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    MANGANESE CARBONATE (UNII: 9ZV57512ZM) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)10 mg  in 1 mL
    SODIUM SELENITE (UNII: HIW548RQ3W) (SELENITE ION - UNII:KXO0259XJ1) SELENIUM5 mg  in 1 mL
    CUPRIC CARBONATE (UNII: 9AOA5F11GJ) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49920-006-011 in 1 BOX
    1100 mL in 1 BOTTLE
    2NDC:49920-006-051 in 1 BOX
    2500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14158209/02/2024
    Labeler - Multimin North America, Inc. (831737239)
    Registrant - Multimin North America, Inc. (831737239)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech196078976manufacture
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    Tairgi Tread-Lia Baile Na Sceilge Teoranta (DbA Ballinskelligs Veterinary Products [BVP]986182178manufacture, analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    Quality Chemicals, S.L.565078185analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    Purity Chemicals465450491api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Grillo Zincoxide GmBH315419200api manufacture