Label: MAKESENSE- miconazole cream

  • 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 July 31, 2014

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  • Active Ingredient

    Miconazole 2.0%

  • Purpose

    Antifungal

  • Uses

    ■ Cures most athlete's foot, jock itch, and ringworm

    ■ relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

  • Warnings

    For external use only.

  • Do not use

    ■ on children under 2 years of age except under the advise and supervision of a doctor ■ for diaper rash

  • When using this product

    ■ avoid contact with eyes

  • Stop use and ask a doctor if

    ■ irritation occurs ■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (jock itch)

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    ■ wash affected area and dry thoroughly ■ apply a thin layer over affected area twice daily  (morning and night) or as directed by a doctor ■ supervise children in the use of this product ■ for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day ■ for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks ■ if conditions persist longer, ask a doctor ■ this product is not effective on the scalp or nails.

  • Other Information

    ■  store at 59 to 86F (15 to 30C)

  • Inactive Ingredients

    Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Stearate

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MAKESENSE 
    miconazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-208
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-208-2828 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/15/2014
    Labeler - Cherry Hill Sales Co (145959768)
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