PRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]

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PRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]
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NDC 67234-014-01
Set ID be06dd85-e342-4f07-b0e4-c49b3f6b3b4b
Category HUMAN OTC DRUG LABEL
Packager Natureplex, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot, jock itch, and ringworm
    • relieves itching, burning, cracking, scaling and discomfort
  • Warnings

    For external use only.

    Avoid contact with eyes.

    Do not use on children under 2 years of age unless directed by a doctor.

    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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in 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, consult a doctor
    • this product is not effective on scalp or nails
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 42 g Tube Carton

    Natureplex™

    NATUREPLEX
    QUALITY
    GUARANTEED

    Pro-Ex
    clotrimazole cream

    NET WT. 1.5 Oz.
    (42g)

    Principal Display Panel - 42 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PRO-EX  ANTI FUNGAL
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-014-0142 g in 1 TUBE; Type 0: Not a Combination Product01/22/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/22/2008
    Labeler - Natureplex, LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex, LLC062808196manufacture(67234-014)
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