MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]

MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]
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NDC 69396-014-05, 69396-014-20
Set ID 80217dbb-a0f0-414a-8d22-a9a346b017aa
Category HUMAN OTC DRUG LABEL
Packager Trifecta Pharmaceuticals Usa Llc
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Drug Facts

  • Active ingredient

    Miconazole Nitrate 2%

  • Purpose

    Anti-Fungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
    • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
  • Warnings

    For external use only. Do not use if the safety-sealed tube is punctured or damaged.

    Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes.

    Stop use and ask a healthcare professional if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

  • Directions

    Clean the affected area and dry thoroughly • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product.

    For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.

    For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.

    For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

    This product is not effective on the scalp or nails.

  • INACTIVE INGREDIENT

    Inactive ingredients Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, glyceryl distearate, mineral oil, peregal-o, purified water, stearic acid, triethanolamine, petrolatum.

  • Other Information

    • Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

    You may report serious side effects to: QC@trifecta-pharma.com

  • SPL UNCLASSIFIED SECTION

    FAST RELIEF 100% GUARANTEED

    Relieves Itching and Burning

    Also Cures Athlete's Foot and Ringworm

    Distributed by:
    Trifecta Pharmaceuticals USA TM
    101 NE Third Avenue Suite 1500
    Ft. Lauderdale, FL 33301 USA
    www.trifecta-pharma.com

  • Packaging

    Miconazole new

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-014
    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
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-014-201 in 1 BOX03/22/2016
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-014-0515 g in 1 TUBE; Type 0: Not a Combination Product03/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/22/2016
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)