Cool Relief Cream
FDA Label NDC 83313-0034

10 label sections · Submitted to the FDA by Zenmed Raging Creations Ltd. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zenmed Raging Creations Ltd. for the product Cool Relief (NDC 83313-0034). 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 other, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS:

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.

Active Ingredient

WITCH HAZEL DISTILLATE (35%).

Purpose

TEMPORARY PAIN RELIEVER

Uses

FOR THE TEMPORARY RELIEF OF ANORECTAL DISCOMFORT ASSOCIATED WITH HEMORRHOIDS.

Warnings

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

KEEP OUT OF REACH OF CHILDREN

Directions

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

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.

Principal Display Panel - 2 Oz Tube Carton

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)

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