EQUATE JOCK ITCH (CLOTRIMAZOLE) CREAM [WALMART STORES INC]

EQUATE JOCK ITCH (CLOTRIMAZOLE) CREAM [WALMART STORES INC]
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NDC 49035-253-21
Set ID 179141aa-b416-40bd-ab82-449f832dcac3
Category HUMAN OTC DRUG LABEL
Packager WALMART STORES INC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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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