Label: HYDROCORTISONE HC- hydrocortisone cream

  • 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, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient
    Hydrocortisone 1%
  • PURPOSE

    Purpose
    Anti-itch

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    if swallowed, get medical help or contact a Poison Control

  • INDICATIONS & USAGE

    Uses
    temporarily relieves itching
    associated with minor skin irritation, inflammation and rashes due to :

    •   psoriasis
    •   seborrheic dermatitis
    •   poison ivy,oak,sumac
    •   insect bites


    Other uses of this product: ask a doctor

  • WARNINGS

    Warnings
    For external use only
    Do not use

        * in or near the eyes
        * by putting directly into the rectum by using figers or any mechanical device
          or applicator
        * for diaper rash; ask a doctor

  • DOSAGE & ADMINISTRATION

    Directions

    • apply to affected area not more than 3 to 4 time daily
    • for external anal itching: when practical, clean area with mild soap and warm
  • INACTIVE INGREDIENT

    Inactive ingredients
    Cetyl alcohol, Buthylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myreistoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water
    Hydrocortosone

  • PRINCIPAL DISPLAY PANEL

    hydrocortisone
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  HC
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0002
    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
    Cetyl alcohol (UNII: 936JST6JCN)  
    Glycerin (UNII: PDC6A3C0OX)  
    Squalane (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0002-41 in 1 BOX
    125 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/15/2010
    Labeler - Neopharm Co,. Ltd (631101883)
    Registrant - Neopharm Co,. Ltd (631101883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neopharm Co,. Ltd 631101883manufacture
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