HYGROMIX 8 (HYGROMYCIN B) GRANULE [ELANCO US INC.]

HYGROMIX 8 (HYGROMYCIN B) GRANULE [ELANCO US INC.]
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NDC 58198-2080-9
Set ID ceb6d885-8afd-4051-9202-71748dcc33bd
Category VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Packager Elanco US Inc.
Generic Name
Product Class
Product Number
Application Number NADA010918
  • SPL UNCLASSIFIED SECTION

    Hygromycin B

    An Anthelmintic Type A Medicated Article

    CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

    For Use in Chicken and Swine Feeds Only

    For Further Manufacturing Only

    Active Drug Ingredient: Hygromycin B - 8 g per pound.

    Important: Must be mixed in feeds before use. Follow mixing directions carefully.

  • Indications:

    Chickens: As an aid in the control of infections of the following intestinal parasites: Large roundworms (Ascaris galli), cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignata).

    Swine: As an aid in the control of infections of the following intestinal parasites: Large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum) and whipworms (Trichuris suis).

    IndicationsAppropriate Concentration of Hygromycin B in Type C Medicated Feed
    Chickens: As an aid in the control of infections of the following intestinal parasites: Large roundworms (Ascaris galli), cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignata). 8 to 12 g/ton
    Swine: As an aid in the control of infections of the following intestinal parasites: Large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum) and whipworms (Trichuris suis). 12 g/ton

    Inactive Ingredient: Soybean meal.

  • Mixing Directions:

    Chickens: Thoroughly mix Hygromix 8 Type A Medicated Article with feed to provide a Type B medicated feed containing up to 132 grams hygromycin B per ton or to provide a complete Type C medicated feed containing 8 to 12 g hygromycin B per ton. When manufacturing Type C medicated feed by directly mixing Hygromix 8 with the finished feed, thoroughly mix Hygromix 8 with a small quantity of finished feed before incorporation into the bulk of the finished feed.

    Pounds to Hygromix 8 to add per ton to make a Type B Medicated FeedResulting Hygromycin B Concentration in Type B Medicated Feed (Grams/Ton)Resulting Hygromycin B Concentration in Type B Medicated Feed (Grams/Pound)
    3.0 24 0.012
    6.0 48 0.024
    12.0 96 0.048
    16.5 132 0.066
    Pound of Hygromycin 8 to add per ton of Type C Medicated FeedResulting Hygromycin B Concentration in Type C Medicated Feed
    1.00 8 g/ton
    1.25 10 g/ton
    1.50 12 g/ton

    Swine: Thoroughly mix Hygromix 8 Type A Medicated Article with feed to provide a Type B medicated feed containing up to 132 grams hygromycin B per ton or to provide a complete Type C medicated feed containing 12 g hygromycin B per ton. When manufacturing Type C medicated feed by directly mixing Hygromix 8 with the finished feed, thoroughly mix Hygromix 8 with a small quantity of finished feed before incorporation into the bulk of the finished feed.

    Pounds of Hygromix 8 to add per ton to make a Type B Medicated FeedResulting Hygromycin B Concentration in Type B Medicated Feed (Grams/Ton)Resulting Hygromycin B Concentration in Type B Medicated Feed (Grams/Pound)
    3.0 24 0.012
    6.0 48 0.024
    12.0 96 0.048
    16.5 132 0.066
    Pounds of Hygromix 8 to add per ton of Type C Medicated FeedResulting Hygromycin B Concentration in Type C Medicated Feed
    1.50 12 g/ton
  • Feeding Directions:

    Chickens: Feed 8-12 g/ton in complete feed.

    Swine: Feed 12 g/ton in complete feed. In Market Hogs: Use Hygromix 8 for 8 weeks during the growing period.

    NOT FOR HUMAN USE

  • RESIDUE WARNING:

    Chickens: Feeds containing Hygromix 8 must be withdrawn 3 days before slaughter.

    Swine: Feeds containing Hygromix 8 must be withdrawn 15 days before slaughter.

    USER SAFETY WARNINGS: When mixing and handling Hygromix 8 Type A Medicated Article, use protective clothing, impervious gloves and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. Do not breathe dust. Since it may cause severe and potentially permanent eye damage, do not get on skin or in eyes. Appropriate eye protection to avoid eye/dust contact is required. In case of eye contact, flush with water and obtain prompt medical aid. Avoid contact with skin surfaces. For skin exposure, wash with soap and water. In case of ingestion, induce vomiting. The safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information or obtain additional product information, call 1-800-428-4441.

    CAUTION: In gilts to be used as breeding stock: Do not use Hygromix 8 because of hearing and vision impairment side effects. In sows: Consideration should be given to hearing and vision impairment side effects. If fed, use for no longer than 8 weeks during gestation and lactation. A reduced response to sound and vision has been noticed in some swine fed Hygromix 8. This impairment of hearing and vision is not an important problem in the market hog. It should, however, be carefully evaluated for breeding stock. Should sows be affected, they will become less responsive to the squeal of baby pigs, possibly resulting in crushed pigs. Store at or below 25°C (77°F). Excursions permitted to 40°C (104°F).

    Not to be used after the date printed on the bag.

    NADA # 10-918, Approved by FDA

    Restricted Drug (California) – Use Only as Directed

    Manufactured for:

    Elanco US, Inc.

    2500 Innovation Way,

    Greenfield, IN 46140, USA

    Product of China

    To report adverse effects, access medical information or obtain additional product information, call 1-800-428-4441

    Elanco, Hygromix and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

    Figure

  • Principal Display Panel - Hygromix 8 Bag Label

    Elanco™

    AF2080

    Hygromix™ 8

    Net Weight: 25 kg
    (55.12 lb)

    Principal Display Panel - Hygromix 8 Bag Label
  • INGREDIENTS AND APPEARANCE
    HYGROMIX 8 
    hygromycin b granule
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:58198-2080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYGROMYCIN B (UNII: 3XQ2233B0B) (HYGROMYCIN B - UNII:3XQ2233B0B) HYGROMYCIN B8 g  in 0.45 kg
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-2080-925 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01091812/15/2011
    Labeler - Elanco US Inc. (966985624)

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