FORTICEPT GREEN BUTTER ANTIMICROBIAL GEL (BENZETHONIUM CHLORIDE) GEL [COSCO INTERNATIONAL, INC.]

FORTICEPT GREEN BUTTER ANTIMICROBIAL GEL (BENZETHONIUM CHLORIDE) GEL [COSCO INTERNATIONAL, INC.]
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NDC 52261-0703-0, 52261-0703-1
Set ID ef7846ce-7fc7-4b1e-8d62-cda572ee2418
Category OTC ANIMAL DRUG LABEL
Packager Cosco International, Inc.
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredients

    Benzethonium Chloride .................................................................................................0.1% Thymol .......................................................................................................................0.1%

    Inactive ingredients:

    Emollients, botanical extracts, and FD&C colors.............................................................99.8%

    Uses

    For external use only * Not for human use * Keep out of reach of children *

    When using this product - avoid eye contact. Stop use and ask a veterinarian if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture wounds, animal bites or serious burns unless directed by a veterinarian.

  • Warnings

    For external use only * Not for human use * Keep out of reach of children * When using this product - avoid eye contact. Stop use and ask a veterinarian if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture wounds, animal bites or serious burns unless directed by a veterinarian.

  • Directions for use

    Wash and dry affected skin. Put a thin layer of ForticeptTM Blue Butter Gel on the affected skin. Cover with a clean or sterile bandage if practical or necessary. Repeat procedure twice daily or as needed until condition improves.

  • Storage and handling

    Keep container closed when not in use. Store at room temperature. Do not expose to temperatures below 32F/0oC or above 95F/35oC for extended periods.

  • FIRST AID

    Eye contact:  In case of contact, immediately flush eyes with cool running water. Remove contact lenses and continue flushing with plenty of water for at least 15 minutes. Get medical attention if irritation persists.

    Skin contact: Wash the skin with water and soap. Wash clothing before reuse.

    Ingestion: DO NOT induce vomiting unless directed to do so by medical personnel. If large quantities of this material are swallowed, call a poison control center immediately.

  • 150g Front Label

    150g Front Label

  • 150g PLPDP

    150g PLPLDP

  • 240g Front Label

    240g Front Label

  • 240g PLPDP

    240g PLPDP

  • INGREDIENTS AND APPEARANCE
    FORTICEPT GREEN BUTTER ANTIMICROBIAL GEL 
    benzethonium chloride gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:52261-0703
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzethonium chloride (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) benzethonium chloride1 g  in 1000 g
    thymol (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) thymol1 g  in 1000 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-0703-0150 g in 1 CAN
    2NDC:52261-0703-1240 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/29/2016
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141api manufacture, label, pack

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