Label: DERMAREST ECZEMA MEDICATED- hydrocortisone lotion

  • NDC Code(s): 63736-339-24
  • 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 January 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Dermarest™ Eczema
    Medicated Lotion

    Keep carton for future reference.

    Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    temporary relief of itching associated with

    • minor skin irritations
    • inflammation
    • rashes due to eczema

    Other uses of this product should be only under the advice and supervision of a doctor.

  • Warnings

    For external use only

    Do not use

    for the treatment of diaper rash

    When using this product

    do not get into the eyes.

    Stop use and ask a doctor if

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

    Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

    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 and children 2 years of age and olderapply to affected area not more than 3 to 4 times daily
    children under 2 years of agedo not use, consult a doctor
  • Other Information

    • shake well
    • store at room temperature 15° - 25°C (59°- 77°F)
  • Inactive ingredients

    Purified water, propylene glycol, glycerin, cetyl alcohol, glyceryl stearate, dimethicone, aleurites moluccana seed oil, zinc PCA, panthenol, carthamus tinctorius (safflower) flower extract, camellia sinensis leaf extract, rheum palmatum root/stalk extract, cyclohexasiloxane, cyclopentasiloxane, xanthan gum, disodium edetate, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben

  • Questions?

    1-800-344-7239 www.Dermarest.com

  • PRINCIPAL DISPLAY PANEL 

    Dermarest®

    Eczema
    Medicated
    Lotion

    Hydrocortisone 1%
    Anti-Itch Lotion
    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL Dermarest® Eczema Medicated Lotion Hydrocortisone 1% Anti-Itch Lotion 4 FL OZ (118 mL)

  • INGREDIENTS AND APPEARANCE
    DERMAREST  ECZEMA MEDICATED
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-339
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-339-2424 in 1 CASE09/20/2010
    11 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34809/20/2010
    Labeler - Insight Pharmaceuticals LLC (055665422)
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