Label: EQUATE JOCK ITCH- clotrimazole cream

  • 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 August 17, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole USP 1% w/w

  • Purpose

    Antifungal Cream

  • Uses

    Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and chafing associated with jock itch.

  • Warnings

    • Do not use on children under 2 years of age unless directed by a doctor.
    • For external use only.
    • Avoid contact with eyes.

    Stop Use and ask a doctor 

    • if irritation occurs or if there is no improvement within two weeks.

    • Keep this and all drugs out of the reach of children.

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

  • Directions

    <This product is not effective on the scalp or nails.

    • Clean the affected area and dry thoroughly.
    • Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.
    • Supervise children in the use of this product.
    • use daily for 2 weeks.
    • If conditions persists longer, consult a doctor.>
  • Other information

    • Store at controlled room temperature 20°-25°C (68°-77°F).
    • Close cap tightly after use.
  • Inactive ingredients

    aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

  • Questions?

    For Questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

  • Principal Display Panel – 1 oz. Tube

    Equate Jock Itch  NDC 49035-253-21

    CLOTRIMAZOLE ANTI-FUNGAL CREAM

    CREAM USP, 1%

    Cures Most Athlete's Foot NET WT. 0.5oz ( 14.2 g)

    Principal Display Panel – 0.5 oz. Tube

  • Principal Display Panel – 0.5 oz. Carton

    Equate Jock Itch NDC 49035-253-21

    Cures Most

    Athlete's Foot

    Relieves Itching, Burning, Scaling, Discomfort and Chafing

    CLOTRIMAZOLE ANTI-FUNGAL CREAM

    CREAM USP, 1%

    *Compare To the active ingredient in Lotrimin-AF®

    NET WT. 0.5oz (14.2g)

    Principal Display Panel – 0.5 oz. Carton

    Principal Display Panel – 0.5 oz. Carton
  • INGREDIENTS AND APPEARANCE
    EQUATE JOCK ITCH 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-253-211 in 1 CARTON08/31/2016
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/31/2016
    Labeler - WALMART STORES INC (051957769)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(49035-253)
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