Label: DERMOSCRIBE ICHYBUM- hydrocortisone, clioquinol, zinc oxide cream
- NDC Code(s): 69683-101-11
- Packager: DERMOSCRIBE PTY LTD
- 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
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- INDICATIONS & USAGE
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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.
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INGREDIENTS AND APPEARANCE
DERMOSCRIBE ICHYBUM
hydrocortisone, clioquinol, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69683-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g CLIOQUINOL (UNII: 7BHQ856EJ5) (CLIOQUINOL - UNII:7BHQ856EJ5) CLIOQUINOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength ZINC OXIDE (UNII: SOI2LOH54Z) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69683-101-11 28 g in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/23/2015 Labeler - DERMOSCRIBE PTY LTD (742164734)