TOUCHLESS CARE ANTIFUNGAL SPRAY [CRAWFORD HEALTHCARE, INC.]

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TOUCHLESS CARE ANTIFUNGAL SPRAY [CRAWFORD HEALTHCARE, INC.]
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NDC 69502-001-57
Set ID 48a7a01e-3480-45bf-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Crawford Healthcare, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • Active Ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Indications

    • Treats jock itch, ringworm and athlete's foot
    • For the treatment of most superficial skin irritations caused by yeast (Candida albicans). Follow a physician's instructions when treating Candida.
  • Warnings

    Do not use on children under 2 years of age unless directed by a doctor. Not intended for ingestion. Do not use for diaper rash. For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    • irritation develops
    • there is no improvement within 4 weeks for athlete's foot or ringworm or within 2 weeks for jock itch.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

  • Directions

    • Cleanse the affected area and allow to dry.
    • Shake bottle well before use.
    • Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician. No rub-in is required.
    • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, contact a doctor. This product is not effective on the scalp or nails.
  • Other Information

    Store at 59 oF - 87 oF (15 oC - 30 oC)

  • Inactive Ingredients

    Cyclomethicone, Dimethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum, Zinc Oxide

  • SPL Unclassified Section

    Distributed by: Crawford Healthcare, Inc. Doylestown, PA 18901

    Touchless Care is a registered trademark of Crawford Woundcare Ltd.

    © Crawford Healthcare Ltd., 2016

    www.crawfordhealthcare.com/us

    1-855-522-2211

    Made in the USA

  • Package Label

    Antifungal label

    antifungal label

  • INGREDIENTS AND APPEARANCE
    TOUCHLESS CARE ANTIFUNGAL 
    touchless care antifungal spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69502-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69502-001-5757 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/28/2017
    Labeler - Crawford Healthcare, Inc. (042813710)
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