Label: CVS FEMININE INTIMATE POWDER- miconazole nitrate powder

  • 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 March 27, 2020

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  • Drug Facts

    Active ingredient
    Miconazole Nitrate 2%

  • Purposes

    Antifungal 

  • Uses

    • for the treatment and relief of external genital itching
    • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with external genital itching
  • Warnings

    For external use only

    Do not use on children under 2 years of age unless directed by a doctor.

    When using this product avoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs or if there is no improvement within 2 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 doctor 
    • supervise children in the use of this product 
  • Other information

    • store between 59°-86°F
    • lightly shake bottle to loosen settled powder
  • Inactive ingredients

    Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Nylon-12, Silica, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

  • PRINCIPAL DISPLAY PANEL

    Image

  • INGREDIENTS AND APPEARANCE
    CVS FEMININE INTIMATE POWDER 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-244
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    NYLON-12 (UNII: 446U8J075B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-244-0785 g in 1 BOTTLE; Type 0: Not a Combination Product05/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/31/2019
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture(59088-244)
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