RASH RELIEF ANTIFUNGAL (MICONAZOLE) LIQUID [TOUCHLESS CARE CONCEPTS LLC]

RASH RELIEF ANTIFUNGAL (MICONAZOLE) LIQUID [TOUCHLESS CARE CONCEPTS LLC]
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NDC 15071-804-11
Set ID 4114c685-acd1-4c65-842b-1cb7840852dc
Category HUMAN OTC DRUG LABEL
Packager Touchless Care Concepts LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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)