EQUALINE CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [SUPERVALU INC]

EQUALINE CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [SUPERVALU INC]
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NDC 41163-264-68, 41163-264-69
Set ID 7ea0e05b-2890-4b2f-9985-3a5113156e41
Category HUMAN OTC DRUG LABEL
Packager SUPERVALU INC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active ingredient                                                                           Purpose

    Clotrimazole 1% ........................................................................Antifungal

  • ACTIVE INGREDIENT

    Active ingredient                                                                           Purpose

    Clotrimazole 1% ........................................................................Antifungal

  • PURPOSE

    Uses

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

    Warnings

    Do not use on children under 2 years of age except under the advice and supervision of a doctor

    For external use only

  • 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 (jock itch)
    • do not use for diaper rash
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
    • 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 sock at least once a day
    • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
    • if conditions persist longer, ask a doctor
    • this product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    Store between 20 o to 25 oC (68 o to 77 oF)

    Lot No. and Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzyl alcohol, cetanol, liquid paraffin, octyldodecanol, polysorbate 60, propylene glycol, purified water, sodium hydroxide, sorbitan monostearate, stearic acid, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY

    SUPERVALU INC

    EDEN PRAIRIE,

    MN 55344 USA

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EQUALINE CLOTRIMAZOLE ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-264
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-264-691 in 1 CARTON09/29/2011
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41163-264-681 in 1 CARTON09/29/2011
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/29/2011
    Labeler - SUPERVALU INC (006961411)