Label: MONISTAT COMPLETE CARE INSTANT ITCH RELIEF- hydrocortisone cream

  • NDC Code(s): 63736-029-01
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves external genital itching
    • other uses of this product should be only under the advice and supervision of a physician
  • Warnings

    For external use only.

    Ask a doctor before use if

    you have a vaginal discharge.

    When using this product

    • avoid contact with eyes
    • do not use more than directed
    • do not begin use of any other hydrocortisone product unless you have asked a doctor

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • adults: apply to affected area not more than 3-4 times daily
    • children under 12 years of age: ask a doctor
  • Other Information

    • store at 20°-25°C (68°-77°F). Protect from freezing and excessive heat.
  • Inactive ingredients

    aloe vera leaf, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, polyoxyl 20 cetostearyl ether, water

  • Questions?

    1-877-666-4782 Monistat.com

  • PRINCIPAL DISPLAY PANEL

    MONISTAT Care® 

    Itch Relief Cream

    Hydrocortisone 1%

    NEW WT 1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL MONISTAT Care® Itch Relief Cream Hydrocortisone 1% NEW WT 1 OZ (28 g)

  • INGREDIENTS AND APPEARANCE
    MONISTAT COMPLETE CARE INSTANT ITCH RELIEF 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    CETEARETH-6 (UNII: 2RJS3559D3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-029-011 in 1 CARTON11/15/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/15/2013
    Labeler - Insight Pharmaceuticals LLC (055665422)
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