国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ), CLIOQUINOL (UNII: 7BHQ856EJ5) (CLIOQUINOL - UNII:7BHQ856EJ5)
DERMOSCRIBE PTY LTD
TOPICAL
OTC DRUG
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.
OTC monograph not final
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._ ---------- 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 DERMOSCRIBE ICHYBUM hydrocortisone, clioquinol, zinc oxide cream PRODUCT 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 DERMOSCRIBE PTY LTD 1 NDC:69683-101- 11 28 g in 1 BOTTLE; Type 0: Not a Combination Product 03/23/201 阅读完整的文件