Label: TOUCHLESS CARE ANTIFUNGAL spray

  • NDC Code(s): 69502-001-57
  • Packager: Crawford Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 16, 2017

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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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