FDA.reportPublic FDA data

COOL RELIEF

Manufacturer
ZENMED Raging Creations Ltd. | Sun Deep Inc.
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-23 01:02:09

Label at a glance#

ProductCool Relief
Active ingredientHAMAMELIS VIRGINIANA TOP WATER
Label structure9 sections

Indications and uses

FOR THE TEMPORARY RELIEF OF ANORECTAL DISCOMFORT ASSOCIATED WITH HEMORRHOIDS.

Dosage and administration

APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 6 TIMES DAILY OR AFTER EACH BOWEL MOVEMENT. WASH HANDS THOROUGHLY BEFORE AND AFTER USE.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

WITCH HAZEL DISTILLATE (35%).

PURPOSE

OTC - PURPOSE SECTION

TEMPORARY PAIN RELIEVER

USES

INDICATIONS & USAGE SECTION

FOR THE TEMPORARY RELIEF OF ANORECTAL DISCOMFORT ASSOCIATED WITH HEMORRHOIDS.

WARNINGS SECTION

FOR EXTERNAL USE ONLY. IF YOUR CONDITION DOES NOT IMPROVE AFTER 7 DAYS OR BLEEDING OCCURS, CONSULT A DOCTOR.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

DO NOT INSERT THIS PRODUCT INTO THE RECTUM USING FINGERS OR APPLICATOR. IF CHILDREN UNDER 12 YEARS OF AGE, PREGNANT OR BREAST-FEEDING, CONSULT A HEALTH PROFESSIONAL BEFORE USE.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 6 TIMES DAILY OR AFTER EACH BOWEL MOVEMENT. WASH HANDS THOROUGHLY BEFORE AND AFTER USE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

PURIFIED WATER, EXTRACTS OF SAGE, COLTSFOOT, YARROW, BALM MINT, CHAMOMILE, ROSEMARY, ALTHEA, WILD THYME & HORSETAIL, VEGETABLE GLYCERIN, CERTIFIED ORGANIC SUNFLOWER OIL & ALOE VERA GEL, VITAMINS A, D3 & E, SOY LECITHIN, COCOA BUTTER, STEARIC ACID, OCTYL PALMITATE, ALLANTOIN, BENZYL ALCOHOL, PHENOXYETHANOL, ETHYL HEXYL GLYCERIN. 100% VEGAN FORMULATION.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

CALL: 1-888-749-4998
VISIT: ZENMED.COM
EMAIL: INFO@ZENMED.COM

PRINCIPAL DISPLAY PANEL - 2 oz Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COOL RELIEF
HEMORRHOID TREATMENT CREAM

ZENMED®
Creating Products With Conscience

VEGAN,
PLANT-BASED

CRUELTY-FREE
CERTIFIED

Quickly Relieves Pain,
Itching & Discomfort

Made with 100% Natural
Witch Hazel & Certified
Organic Sunflower Oil
and Aloe Vera Gel

2 oz | 60 fl. oz

Principal Display Panel - 2 oz Tube Carton
Principal Display Panel - 2 oz Tube Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83313-003483313-0034-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VACTIB
WATER059QF0KO0RIACT
SAGE065C5D077JIACT
TUSSILAGO FARFARA0JXZ63016VIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
CHAMOMILEFGL3685T2XIACT
ROSEMARYIJ67X351P9IACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
WILD THYMEKXK6I80R8WIACT
SUNFLOWER OIL3W1JG795YIIACT
ALOE VERA LEAFZY81Z83H0XIACT
VITAMIN A81G40H8B0TIACT
CHOLECALCIFEROL1C6V77QF41IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
COCOA BUTTER512OYT1CRRIACT
STEARIC ACID4ELV7Z65APIACT
OCTYL PALMITATEUYY8LE6Q5YIACT
ALLANTOIN344S277G0ZIACT
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.