Label: BOTANIMEDIX ONYCHORX ANTIFUNGAL NAIL GEL- undecylenic acid gel

  • NDC Code(s): 52261-5800-0, 52261-5800-1
  • Packager: Cosco International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 29, 2020

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  • DRUG FACTS

    Active Ingredient Purpose
    Undecylenic Acid 25%........................Anti-fungal

  • Uses:

    For the cure of most Tinea Pedis (athlete's foot) and Tinea Corporis (ringworm)

    For relief of:

    Itching, Burning, Redness, Irratation, Scaling, Soreness
    Discomfort which may accompany these conditions

  • Directions:

    Apply twice daily for best results.

  • Warnings:

    For external use only.

    When using this product

    • Do not get into eyes.

    Stop use and ask a doctor if:

    • Condition worsens.
    • Symptoms last more than 7 days or clear and occur again within a few days.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.

    Inactive Ingredients:

    Alpha Tocopheryl Acetate (Vitamin E), Cannabidiol, Cetostearyl Alchohol, Clove Leaf Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propolis Wax, Tea Tree Oil, Urea, Water

    Questions?

    Call: 1-800-964-5406

    www.botanimedix.com

    Distributed by:

    BotaniMedix

    Atlanta, GA 30067

  • PRINCIPAL DISPLAY PANEL

    labellabellabel

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    BOTANIMEDIX ONYCHORX ANTIFUNGAL NAIL GEL 
    undecylenic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-5800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID0.2508 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    UREA (UNII: 8W8T17847W)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-5800-01 in 1 CARTON01/01/2020
    1NDC:52261-5800-10.002 kg in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2020
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-5800) , label(52261-5800) , pack(52261-5800)
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