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
  • Marketing Status: OTC monograph not 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 6, 2018

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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 only be under the advice and supervision of a doctor
  • 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

    ammonium acryloyldimethyltaurate/VP copolymer, carbomer, ceteareth-6, cetyl alcohol, citric acid, dimethicone, edetate disodium, ethylparaben, glycerin, methylparaben, mineral oil, petrolatum, phenoxyethanol, propylparaben, sodium citrate, sodium hydroxide, stearyl alcohol, VP/eicosene copolymer, water

  • Questions?

    1-877-666-4782 Monistat.com

    Dist. by Insight Pharmaceuticals, LLC. 
    Tarrytown, NY 10591

    A Prestige Brands Company

  • 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 NOT FINALpart34811/15/2013
    Labeler - Insight Pharmaceuticals LLC (055665422)
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