Label: RASH RELIEF ANTIFUNGAL- miconazole liquid

  • 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 November 16, 2011

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  • Active Ingredients

    Miconazole Nitrate      2%

    Dimethicone             10%       

    Petrolatum               10%


  • Purpose

    Antifungal / Skin Protectant

  • Warnings

    - Ask a doctor before use on children under the age of two.  For external use only.

    - When using this product do not get into eyes. 

    - 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.

  • Directions

    - Clean the affected area and dry thoroughly. 

    - 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.


  • Inactive Ingredients

    Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum

  • INDICATIONS & USAGE

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

  • KEEP OUT OF REACH OF CHILDREN

    - Keep out of reach of children.  If swallowed, get medical help or contact a local poison control center immediately

  • PRINCIPAL DISPLAY PANEL

    RRAF

  • INGREDIENTS AND APPEARANCE
    RASH RELIEF ANTIFUNGAL 
    miconazole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15071-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate2 g  in 100 g
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone10 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Mineral Oil (UNII: T5L8T28FGP)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Lanolin (UNII: 7EV65EAW6H)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Hexamethyldisiloxane (UNII: D7M4659BPU)  
    Water (UNII: 059QF0KO0R)  
    Cholecalciferol (UNII: 1C6V77QF41)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15071-804-1156 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/14/2006
    Labeler - Touchless Care Concepts LLC (083459334)
    Registrant - Touchless Care Concepts LLC (083459334)
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