Active Ingredients
MENTHOL 1%
Zhong Hua Jiu Patch
FDA Label NDC 53614-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wuhan Chinese Moxibustion Technology Development Co.; Ltd. for the product Zhong Hua Jiu Patch (NDC 53614-001). 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 active ingredients, purpose, warnings, do not use, when using this product, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
EXTERNAL ANALGESIC
FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS DUE TO: ARTHRITIS, STAINS, BRUISES, SPRAINS, SIMPLE BACKACHE.
Warnings
FOR EXTERNAL USE ONLY.
Do Not Use
ON WOUNDS, IRRITATED OR DAMAGED SKIN, SENSITIVE SKIN
When Using This Product
AVOID CONTACT WITH THE EYES
DO NOT BANDAGE TIGHTLY
DO NOT APPLY TO WOUNDS OR DAMAGED SKIN
DO NOT USE ONE HOUR BEFORE OR AFTER BATHING
Stop Use And Ask A Doctor If
CONDITION WORSENS
SYMPTONS PERSIST FOR MORE THAN SEVEN DAYS
SYMPTONS CLEAR UP AND OCCUR AGAIN WITH A FEW DAYS
EXCESSIVE IRRITATION OF THE SKIN OR BURN DEVELOPS
REDNESS IS PRESENT
Directions
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: REMOVE PATCH FROM THE PROTECTIVE LAYER, APPLY TO THE AFFECTED AREA, AND RUB THE AREA WITH YOUR HAND TO SECURE THE PATCH.
PATCH WILL REMAIN EFFECTIVE FOR 12 HOURS AND WILL BE MROE EFFECTIVE WHEN USED 1 HOUR AFTER BATHING.
DO NOT LEAVE THE PATCH ON THE SAME SPOT FOR MORE THAN 12 HOURS.
DO NOT APPLY TO THE AREA WITH EXCESSIVE HAIR. ADHESIVE PATCH MAY HURT SKIN UPON REMOVAL.
CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE OR CONSULT A DOCTOR.
Other Information
STORE AT ROOM TEMPERATURE 20-25 DEGREES CENTIGRADE (68-77 DEGREES FAHRENHEIT)
Inactive Ingredients
ACTIVATED CHARCOL
ANGELICA BISERRATA ROOT
ARTEMISIA ARGYI LEAF
BOSWELLIA SACRA BARK
IRON
2,4-D SODIUM SALT
WATER
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