Label: INTENSIVE HEALING ECZEMA- hydrocortisone lotion

  • 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 February 4, 2018

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  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Uses

    Temporarily relieves the itching and discomfort associated with minor skin irritations, rashes and inflammation due to excema.

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

  • Warnings

    For external use only.

  • Do not use

    Do not use for the treatment of diaper rash.  Consult a doctor.

  • When using this product

    avoid contact with the eyes.

    do not use more than directed unless told to do so by a doctor.

  • Stop use and ask a doctor if

    condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

  • Keep out of reach of children.

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

  • Directions

    adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily.

    children under 2 years of age: ask a doctor.

  • Inactive Ingredients

    glycerin, methylparaben, propylparaben, petrolatum, cetearyl alcohol, cetyl palmitate, isostearyl neopentanoate, isopropyl myristate, PEG-40 stearate, ceteareth 20, benzyl alcohol, aloe, dimethicone, vitamin A, vitamin D, vitamin E, chamomile extract, sodium citrate, magnesium ascorbyl phosphate (vitamin C), shea butter, EDTA, water

  • Directions

    Apply to affected area not more than 3 to 4 times daily.

  • Label

    LabelLabelLabelLabel

  • INGREDIENTS AND APPEARANCE
    INTENSIVE HEALING ECZEMA 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0670
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1.02 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 64.89 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 15 g  in 100 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 5 g  in 100 g
    CETYL PALMITATE (UNII: 5ZA2S6B08X) 3 g  in 100 g
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) 3 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) 2 g  in 100 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 1.5 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1.0 g  in 100 g
    BENZYL ALCOHOL (UNII: LKG8494WBH) 1.0 g  in 100 g
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) .5 g  in 100 g
    PEG-40 STEARATE (UNII: ECU18C66Q7) .5 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) .5 g  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) .5 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) .2 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) .1 g  in 100 g
    CHAMOMILE (UNII: FGL3685T2X) .1 g  in 100 g
    SODIUM CITRATE (UNII: 1Q73Q2JULR) .1 g  in 100 g
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .02 g  in 100 g
    CHOLECALCIFEROL (UNII: 1C6V77QF41) .02 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) .02 g  in 100 g
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) .02 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) .01 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0670-0499.2 g in 1 TUBE; Type 0: Not a Combination Product03/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/25/2018
    Labeler - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(0363-0670)
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