LAKESIA (CLOTRIMAZOLE) CREAM [OPMX LLC]

LAKESIA (CLOTRIMAZOLE) CREAM [OPMX LLC]
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NDC 69729-064-20
Set ID 19ed56cd-e951-57b6-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager OPMX LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot, jock itch, and ringworm
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • Warnings

    Do not use on children under 2 years of age except under the advice and supervision of a doctor

    For external use only

  • When using this product

    avoid contact with the eyes

  • Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)
    • do not use for diaper rash
  • Keep out of reach of children

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

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer cover affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
    • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
    • if conditions persist longer, ask a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • store between 2°and 30° C (36° and 86° F)

  • Inactive ingredients

    Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Clyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Trolamine, Purified water

  • PRINCIPAL DISPLAY PANEL

    Lakesia

    Lakesia

  • INGREDIENTS AND APPEARANCE
    LAKESIA 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-064-201 in 1 BOX
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/02/2015
    Labeler - OPMX LLC (029918743)

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