JOCK ITCH (CLOTRIMAZOLE) CREAM [THE IBN SINA PHARMACEUTICAL INDUSTRY LTD.]

JOCK ITCH (CLOTRIMAZOLE) CREAM [THE IBN SINA PHARMACEUTICAL INDUSTRY LTD.]
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NDC 72103-525-10
Set ID 84129414-99ce-55c7-e053-2991aa0aadbc
Category HUMAN OTC DRUG LABEL
Packager The IBN SINA Pharmaceutical Industry Ltd.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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 72103-525-10

    Jock Itch Cream

    Clotrimazole Cream, USP 1%

    Antifungal Cream

    Net Wt. 0.35 oz (10g)

    Cures Most Jock Itch

    JOCK ITCH CREAM

  • INGREDIENTS AND APPEARANCE
    JOCK ITCH 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72103-525
    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:72103-525-101 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(72103-525)

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