CLOTRIMAZOLE CREAM [PROMEX, LLC]

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CLOTRIMAZOLE CREAM [PROMEX, LLC]
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NDC 58988-0022-1
Set ID b4155ea9-b2d8-4826-92ee-3f6cfdef09bf
Category HUMAN OTC DRUG LABEL
Packager Promex, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • Cures most athlete's foot, jock itch, and ringworm
    • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • Warnings

    For external use only

    Do not use

    • on children under 2 years of age except under the advice and supervision of a doctor

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • Irritation occursThere is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)Do not use for diaper rash

    Keep out of reach of children

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

  • 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 socks 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
  • Other information

    • store between 2°and 30°C (36°and 86°F)

  • Inactive ingredients

    Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Purified water, Stearic acid and Trolamine

  • PRINCIPAL DISPLAY PANEL

    Clotrimazole

    image of carton label

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0022
    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)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-0022-11 in 1 BOX
    128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/04/2013
    Labeler - Promex, LLC (789974388)
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