Label: FACIL 1.1 CONCENTRATE- none liquid

  • NDC Code(s): 86112-1821-1, 86112-1821-2, 86112-1821-3, 86112-1821-4
  • Packager: Dairy Alarm 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 November 6, 2019

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

  • Safety Data Sheet

    SAFETY DATA SHEET (Abbreviated. For full version, please contact the manufacturer or visit www.udderwash.com)

    1. Identification

    Product identifier Facil 1.1 Concentrate

    Manufacturer

    Dairy Alarm, LLC

    37 Homer Street

    Union Springs, NY 13160

    Website: www.udderwash.com

    Telephone 315-515-9698

    Emergency phone number 565-465-2218

    Reorder: www.udderwash.com or call company at number provided

    2. Mixing and Use Directions

    Add 6 fluid ounces of Facil 1.1 concentrate to a non-metallic container and dilute with clean water to 1 gallon.

    Prior to milking, dip each teat into the mixed solution. Teats should be dipped to the base of the udder. If, or when, the solution becomes visibly dirty or sediment begins to build in the mixture, replace with a fresh batch of new solution mixed as previously described. If possible, a foamer should be used for application to teats.

    3. Hazard(s) identification

    Hazard statement Toxic if swallowed. Causes severe skin burns and eye damage. Causes serious eye damage.

    Toxic to aquatic life.

    Precautionary statement

    Prevention Do not breathe mist or vapor. Wash thoroughly after handling. Do not eat, drink or smoke when

    using this product. Avoid release to the environment. Wear protective gloves/protective

    clothing/eye protection/face protection.

    Response If swallowed: Immediately call a poison center/doctor. If swallowed: Rinse mouth. Do NOT induce

    vomiting. If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with

    water/shower. If inhaled: Remove person to fresh air and keep comfortable for breathing. If in

    eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy

    to do. Continue rinsing. Immediately call a poison center/doctor. Wash contaminated clothing

    before reuse.

    Storage Store locked up.

    Disposal Dispose of contents/container in accordance with local/regional/national/international regulations.

    4. First-aid measures

    Inhalation Move to fresh air.

    Take off immediately all contaminated clothing. Rinse skin with water/shower. Call a physician or

    poison control center immediately. Chemical burns must be treated by a physician. Wash

    contaminated clothing before reuse.

    Skin contact

    Immediately flush eyes with plenty of water for at least 15 minutes. Remove contact lenses, if

    present and easy to do. Continue rinsing. Call a physician or poison control center immediately.

    Eye contact

    Call a physician or poison control center immediately. Rinse mouth. Do not induce vomiting. If

    vomiting occurs, keep head low so that stomach content doesn't get into the lungs. Do not use

    mouth-to-mouth method if victim ingested the substance. Induce artificial respiration with the aid of

    a pocket mask equipped with a one-way valve or other proper respiratory medical device.

    Ingestion

    Burning pain and severe corrosive skin damage. Causes serious eye damage. Symptoms may

    include stinging, tearing, redness, swelling, and blurred vision. Permanent eye damage including

    blindness could result.

    Most important

    symptoms/effects, acute and

    delayed

    Provide general supportive measures and treat symptomatically. Chemical burns: Flush with water

    immediately. While flushing, remove clothes which do not adhere to affected area. Call an

    ambulance. Continue flushing during transport to hospital. Keep victim warm. Keep victim under

    observation. Symptoms may be delayed.

    5. Handling and storage

    Provide adequate ventilation. Do not breathe mist or vapor. Do not get in eyes, on skin, or on

    clothing. Avoid prolonged exposure. Do not taste or swallow. When using, do not eat, drink or

    smoke. Wear appropriate personal protective equipment. Wash hands thoroughly after handling.

    Avoid release to the environment.

    Precautions for safe handling

    Store locked up. Store in original tightly closed container. Store away from incompatible materials

    (see Section 10 of the SDS).

  • Facil 1.1 Concentrate Label

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  • INGREDIENTS AND APPEARANCE
    FACIL 1.1 CONCENTRATE 
    none liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86112-1821
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N) SODIUM HYPOCHLORITE1 kg  in 1 kg
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) (HYDROXIDE ION - UNII:9159UV381P) POTASSIUM HYDROXIDE1 kg  in 1 kg
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J) (TRIPOLYPHOSPHATE ION - UNII:5798IYA5AY) SODIUM TRIPOLYPHOSPHATE1 kg  in 1 kg
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID1 kg  in 1 kg
    SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6) SODIUM CHLORITE1 kg  in 1 kg
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE1 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86112-1821-12 kg in 1 PAIL
    2NDC:86112-1821-27 kg in 1 PAIL
    3NDC:86112-1821-327 kg in 1 DRUM
    4NDC:86112-1821-4135 kg in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2019
    Labeler - Dairy Alarm LLC (117168486)
    Registrant - Dairy Alarm LLC (117168486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thatcher Company of New York043921993api manufacture, manufacture