Label: FOOT CARE CLOTRIMAZOLE- clotrimazole cream

  • NDC Code(s): 11822-0350-3, 11822-0350-5
  • Packager: Rite Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Clotrimazole 1%

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  • Purpose

    Antifungal

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  • Uses

    • treats most athlete’s foot, jock itch and ringworm
    • relieves itching, scaling, burning, irritation and discomfort
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  • Warnings

    For external use only

    When using this product

    • do not get into the eyes

    Stop use and ask a doctor if

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

    Do not use

    on children under 2 years, unless directed by a doctor.

    Keep out of reach of children.

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

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  • Directions

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
    • supervise children in the use of this product
    • this product  does not work on the scalp or nails

    for athlete’s foot and ringworm

    pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once every day. Use every day for 4 weeks

    for jock itch

    use every day for 2 weeks. If condition lasts longer, contact a doctor

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  • Inactive ingredients

    benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

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  • Questions?

    1-800-432-8534 (select option#2) between 9 am and 4 pm EST, Monday–Friday.

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  • Principal Display Panel

    RITE AID® PHARMACY
    *Compare to the active
    ingredient in Lotrimin® AF
    foot care
    clotrimazole cream 1%
    antifungal
    cures most athlete’s foot
    relieves itching and burning
    greaseless and non-staining

    NET WT 0.5 OZ (14 g)

    foot care clotrimazole label1
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  • INGREDIENTS AND APPEARANCE
    FOOT CARE CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0350
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    CETOSTEARYL ALCOHOL  
    CETYL ESTERS WAX  
    OCTYLDODECYL STEARATE  
    POLYSORBATE 60  
    WATER  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    SORBITAN MONOSTEARATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0350-3 1 in 1 CARTON
    1 14 g in 1 TUBE
    2 NDC:11822-0350-5 1 in 1 CARTON
    2 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 03/12/2010
    Labeler - Rite Aid (014578892)
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