Label: APEX 5000- iodine liquid

  • NDC Code(s): 48106-1186-1, 48106-1186-2, 48106-1186-3, 48106-1186-4, view more
    48106-1186-5, 48106-1186-6
  • Packager: BouMatic, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 1, 2012

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    IODINE BARRIER TEAT DIP

    Helps reduce the spread of organisms
    which may cause Mastitis

    USE DIRECTIONS

    NOT FOR HUMAN USE
    FOR EXTERNAL USE ONLY
    USE AT FULL STRENGTH

    POST-DIPPING: After milking, dip
    entire teat with this product. Allow
    to air dry.

    Note: If solution in cup becomes visibly
    dirty, replenish with a fresh mixture
    of this product. Do not return
    unused product to original container.

    Active Ingredient (Iodine 0.5%)
    Emollients Gylcerin 6%
  • PRECAUTIONS

    CAUTION

    KEEP OUT OF REACH OF CHILDREN
    NOT FOR HUMAN USE

    FIRST AID:
    If in eyes: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present after the first 5 minutes, then continue rinsing. Contact a physician immediately. If swallowed: Have person sip a glass of water if able to swallow. Do not give anything to an unconscious person. Do not induce vomiting. Contact a physician immediately. If breathing difficulty occurs: Move person to fresh air. Contact a physician immediately. If on skin: Take off contaminated clothing. Rinse skin with soap and water. If irritation develops and persists, contact a physician.
    Have the product container or label with you when going for treatment, calling a physician, the emergency number listed on this label or MSDS, or a poison control center.

    PRECAUTION: Avoid eye contact. Do not ingest. Do not mix with any chemicals except as directed.

    STORAGE: Store in a closed container away from sources of heat. If product becomes frozen, thaw and mix well before use.

    SEE MATERIAL SAFETY DATA SHEET

  • PRINCIPAL DISPLAY PANEL

    Blank Label

  • INGREDIENTS AND APPEARANCE
    APEX 5000 
    iodine liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:48106-1186
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE54 mL  in 10 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48106-1186-13.8 L in 1 DRUM
    2NDC:48106-1186-218.9 L in 1 DRUM
    3NDC:48106-1186-356.8 L in 1 DRUM
    4NDC:48106-1186-4114 L in 1 DRUM
    5NDC:48106-1186-5208 L in 1 DRUM
    6NDC:48106-1186-61040 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2007
    Labeler - BouMatic, LLC (124727400)
    Registrant - BouMatic, LLC (124727400)
    Establishment
    NameAddressID/FEIBusiness Operations
    BouMatic, LLC124727400manufacture, api manufacture