Label: LOTRIMIN- clotrimazole cream

  • NDC Code(s): 11523-0963-1, 11523-0963-2, 11523-0963-5, 11523-0963-7
  • Packager: MSD Consumer Care, Inc.
  • 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 08/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Clotrimazole 1%

    Close
  • Purpose

    Antifungal

    Close
  • Uses

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    • 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 spaces between the toes, wear well-fitting, ventilated shoes and 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, ask a doctor
    • this product is not effective on the scalp or nails
    Close
  • Other information

    store between 20° to 25°C (68° to 77°F)

    Close
  • Inactive ingredients

    benzyl alcohol, cetyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, stearyl alcohol, water

    Close
  • Questions?

    866-360-3226

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

    Close
  • PRINCIPAL DISPLAY PANEL - 24 g Tube Carton

    LOTRIMIN®AF

    clotrimazole cream

    ANTIFUNGAL

    NET WT 24g (0.85 OZ)

    Principal Display Panel - 24 g Tube Carton
    Close
  • INGREDIENTS AND APPEARANCE
    LOTRIMIN 
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11523-0963
    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  
    cetyl alcohol  
    cetyl esters wax  
    octyldodecanol  
    polysorbate 60  
    sorbitan monostearate  
    stearyl alcohol  
    water  
    Product Characteristics
    Color WHITE (White to Off-white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-0963-1 1 in 1 CARTON
    1 30 g in 1 TUBE
    2 NDC:11523-0963-2 1 in 1 CARTON
    2 15 g in 1 TUBE
    3 NDC:11523-0963-5 1 in 1 CARTON
    3 12 g in 1 TUBE
    4 NDC:11523-0963-7 1 in 1 CARTON
    4 24 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 02/01/2002
    Labeler - MSD Consumer Care, Inc. (968091715)
    Close