Label: 1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM- clotrimazole 1% antifungal cream cream

  • NDC Code(s): 73750-091-05, 73750-091-10
  • Packager: QYK BRANDS LLC
  • 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 February 4, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Clotrimazole 1%

  • PURPOSE

    Antifungal

    cures most athlete's foot, jock itch and ringworm

    relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

  • WARNINGS

    For external use only

    Do not use on children under 2 years of age unless directed by a doctor

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    irritation occurs
    there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

    Keep out of reach of children.

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

  • STOP USE

    irritation occurs
    there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

  • INSTRUCTIONS FOR USE

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

  • DOSAGE & ADMINISTRATION

    10 milligrams/gram per application

  • INACTIVE INGREDIENT

    benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

  • OTHER SAFETY INFORMATION

    To open: unscrew cap, remove liner seal and replace cap
    Store at USP controlled room temperature 20-25°C (68-77°F)
    see carton or tube crimp for lot number and expiration date

  • INDICATIONS & USAGE

    Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).
    Children under 2 years of age: consult a doctor

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    Tube Print

  • INGREDIENTS AND APPEARANCE
    1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM 
    clotrimazole 1% antifungal cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73750-091
    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
    WATER (UNII: 059QF0KO0R) 69.5 g  in 100 g
    POLYSORBATE 60 (UNII: CAL22UVI4M) 1.5 g  in 100 g
    BENZYL ALCOHOL (UNII: LKG8494WBH) 1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73750-091-1030 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
    2NDC:73750-091-0515 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2022
    Labeler - QYK BRANDS LLC (081560441)
    Registrant - QYK BRANDS LLC (081560441)
    Establishment
    NameAddressID/FEIBusiness Operations
    QYK081560441label(73750-091)