Label: BOTANIMEDIX TINEARX ANTIFUNGAL DRYING EMULSION- clotrimazole cream

  • NDC Code(s): 52261-5801-0, 52261-5801-1
  • 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 30, 2020

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  • DRUG FACTS

    Active Ingredient                          Purpose
    Clotrimazole 1%........................Anti-fungal

  • Uses:

    Cures most athlete's foot, jock itch, and ring worm

  • INDICATIONS & USAGE

    For relief of:

    • Itching, burning, cracking, scaling, and discomfort which 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

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Inactive Ingredients:

    Aluminum Starch Octenylsuccinate, Cannabidiol, Clove Leaf Oil, Dipropylene Glycol, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Myristate, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Ethylhexylglycerin, Polyoxyl 20 Cetostearyl Ether, Tea Tree Oil, Water

    Questions?

    Call:  1-800-964-5406

    www.botanimedix.com

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

    cartoncarton

  • INGREDIENTS AND APPEARANCE
    BOTANIMEDIX TINEARX ANTIFUNGAL DRYING EMULSION 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-5801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.01 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    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)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-5801-01 in 1 CARTON01/30/2020
    1NDC:52261-5801-10.044 kg in 1 TUBE; 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(52261-5801) , label(52261-5801) , pack(52261-5801)
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