Label: ATHLETES FOOT- clotrimazole cream

  • Category: HUMAN OTC DRUG LABEL

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 March 14, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Clotrimazole 1%

  • PURPOSE

    Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    For external use only

  • DO NOT USE

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

  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    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)
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • wash the 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
    • change shoes and 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, consult a doctor
    • this product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    • store at 2° - 30° C (36° - 86° F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetostearyl alcohol, methylparaben, mineral oil, paraffin, polyoxyl 40 hydrogenated castor oil, polysorbate 80, water

  • QUESTIONS

    Questions?

    Call 1-833-IBN-SINA (1-833-426-7462)

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    The IBN SINA Pharmaceutical Industry Ltd.

    Holding # A-80, Ward # 9, Shafipur, Kaliakoir

    Gazipur-1751 Bangladesh

    www.ibnsinapharma.com

    Product of Bangladesh

  • PRINCIPAL DISPLAY PANEL

    NDC 72103-527-10

    Athlete's Foot!

    Clotrimazole Cream, USP 1%

    Antifungal Cream

    Net Wt. 0.35 oz (10g)

    Cures Most Athlete's Foot

    ATHLETES FOOT

  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72103-527
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72103-527-101 in 1 CARTON03/14/2019
    110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/14/2019
    Labeler - The IBN SINA Pharmaceutical Industry Ltd. (731557752)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Ibn Sina Pharmaceutical Industry Ltd.731557752manufacture(72103-527)
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