DERMOSCRIBE ICHYBUM- hydrocortisone, clioquinol, zinc oxide cream 
DERMOSCRIBE PTY LTD

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.

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DERMOSCRIBE (as PLD) - ICHYBUM CREAM (69683-101)

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

PURPOSE

ANAL ITCHING

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

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.

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 INGREDIENTS

ZINC OXIDE, WATER

STORE AT ROOM TEMPERATURE

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

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)

Revised: 10/2023
Document Id: 06d42f39-2499-7b3d-e063-6294a90ab05c
Set id: 134a88a1-13e5-4da0-8270-c380b57aaeb7
Version: 9
Effective Time: 20231003
 
DERMOSCRIBE PTY LTD