Dermoscribe Ichybum Cream
FDA Label NDC 69683-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermoscribe Pty Ltd for the product Dermoscribe Ichybum (NDC 69683-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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

Otc - 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.

Otc - 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

Package Label.Principal Display Panel

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