MICRO-GUARD (AF) (MICONAZOLE NITRATE) POWDER [COLOPLAST MANUFACTURING US, LLC]

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MICRO-GUARD (AF) (MICONAZOLE NITRATE) POWDER [COLOPLAST MANUFACTURING US, LLC]
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NDC 11701-038-16
Set ID a43a94d0-fec0-470f-bdb4-535dcce6d1e0
Category HUMAN OTC DRUG LABEL
Packager Coloplast Manufacturing US, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    For Effective Treatment of Topical Fungal Infections
    AF

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active ingredient

    Miconazole Nitrate, 2%

    Purpose

    Antifungal

    Uses Treats jock itch, ringworm, and athlete's foot ►

    Warnings

    For external use only.

    When using this product

    • avoid contact with the eyes
    • if eye contact occurs, flush with water
    • do not use on children under 2 years of age unless directed by a doctor.

    Stop using this product

    • for athlete's foot or ringworm if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor
    • for jock itch if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.

    Keep this and all drugs out of reach of children.

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

    Directions

    • clean the affected area and dry thoroughly
    • apply over the 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 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 the scalp or nails.

    Inactive ingredients corn starch USP, sodium bicarbonate, tri-calcium phosphate

    Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark
    Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.
    1-800-533-0464 www.us.coloplast.com Product #1337

    ©2008-11, Coloplast Corp. Made in the U.SA

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 3 OZ. (85 g)

    NDC 11701-038-16

    Micro-Guard®Powder
    Antifungal Powder
    With Miconazole
    Nitrate 2%

    For Effective Treatment of Topical Fungal Infections

    AF

    Coloplast

    3 OZ. (85 g)

    L8-640

    Figure
  • INGREDIENTS AND APPEARANCE
    MICRO-GUARD   (AF)
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-038-1685 g in 1 BOTTLE; Type 0: Not a Combination Product06/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-038)
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