Label: DERMOSCRIBE ICHYBUM- hydrocortisone, clioquinol, zinc oxide 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 October 3, 2023

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  • ACTIVE INGREDIENT

    CONTAINS: HYDROCORTISONE 1%, CLIOQUINOL 1%, ZINC OXIDE CREAM

  • PURPOSE

    PURPOSE

    ANAL ITCHING

  • INDICATIONS & USAGE

    DERMOSCRIBE'S ICHYBUM ANAL ITCHING CREAM IS A TOPICAL TREATMENT FOR RELIEF OF THE SYMPTOMS OF PRURITUS ANI AND OTHER AFFLICTIONS INVOLVING CHRONIC ITCHING AROUND THE ANUS.

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

    USE ONLY IN ACCORDANCE WITH DIRECTIONS ON LABEL AND WITHIN THE PACKAGING. SEEK MEDICAL ADVICE IF PREGNANT OR BREASTFEEDING. AVOID EYES. DO NOT SWALLOW. CONSULT A HEALTHCARE PROFESSIONAL ABOUT LONG TERM USE. IF IRRITATION DEVELOPS, SEEK MEDICAL ADVICE. MAY NOT BE AS EFFECTIVE BEYOND EXPIRY DATE. REFER TO ENCLOSED LEAFLET FOR DETAILED DIRECTIONS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS
    •FOR USE ONLY BY ADULTS AND CHILDREN OVER 12 YEARS.
    •APPLY A SMALL AMOUNT IN A THIN LAYER OVER THE AFFECTED AREA ONCE OR TWICE DAILY AS REQUIRED, PREFERABLY AFTER SHOWERING AND/OR BOWEL MOVEMENTS AS WELL AS AT NIGHT BEFORE SLEEP.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    ZINC OXIDE, WATER

  • OTHER SAFETY INFORMATION

    STORE AT ROOM TEMPERATURE

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Revised Final Ichybum Label 61mm x 97mm OUTLINES March 24 2017

  • INGREDIENTS AND APPEARANCE
    DERMOSCRIBE ICHYBUM 
    hydrocortisone, clioquinol, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69683-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    CLIOQUINOL (UNII: 7BHQ856EJ5) (CLIOQUINOL - UNII:7BHQ856EJ5) CLIOQUINOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69683-101-1128 g in 1 BOTTLE; Type 0: Not a Combination Product03/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/23/2015
    Labeler - DERMOSCRIBE PTY LTD (742164734)
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