FORTICEPT BLUE BUTTER ANTIMICROBIAL GEL (BENZETHONIUM CHLORIDE, THYMOL) GEL [LIDAN, INC.]

FORTICEPT BLUE BUTTER ANTIMICROBIAL GEL (BENZETHONIUM CHLORIDE, THYMOL) GEL [LIDAN, INC.]
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NDC 72127-0702-2, 72127-0702-3, 72127-0702-4, 72127-0702-5, 72127-0702-8
Set ID 87fb4c7e-1d7d-4823-b0f2-dc756c7e5492
Category OTC ANIMAL DRUG LABEL
Packager Lidan, 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

    Helps protect animal skin and supports healing of minor wounds, scrapes, burns, and lacerations, including pressure sores, ulcers, and cracked skin. Topical antiseptic to help decrease the risk of infection.

    Rapid-acting with moderate duration of action.

  • 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 Forticept 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 of time.

  • FIRST AID

    Eye contact:  In case of contact, immediately rinse eyes with cool water for 15 minutes. Get medical attention if irritation continues.

    Ingestion: If swallowed 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.

  • PRINCIPAL DISPLAY PANEL

    Blue Butter 4oz Top LabelBlue Butter 4oz Side Label

  • PRINCIPAL DISPLAY PANEL

    Blue Butter 8oz Label

  • INGREDIENTS AND APPEARANCE
    FORTICEPT BLUE BUTTER ANTIMICROBIAL GEL 
    benzethonium chloride, thymol gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:72127-0702
    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:72127-0702-4114 g in 1 CAN
    2NDC:72127-0702-8240 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/29/2016
    Labeler - Lidan, Inc. (014456716)
    Registrant - Lidan, Inc. (014456716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141api manufacture, analysis, manufacture, label, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmex Group, LLC365309015manufacture, label, pack, repack

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