Announcement of the General Administration on the revision of the instruction manual for a sweep of ointments

According to the results of the evaluation of adverse drug reactions, in order to further ensure the safety of public drug use, the State Administration of Food and Drug Administration has decided to add warning words to the instruction manual of a sweeping ointment, and to revise the items "functional treatment", "adverse reaction", "taboo" and "precautions". The relevant matters are heeded as follows:
First, all ointment production enterprises shall, in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, in accordance with the revision requirements of the flash ointment instructions (see annex), put forward a supplementary application for revision of the instructions, and report to the provincial food and drug regulatory departments for the record by November 25, 2016.
of the amendment relates to the drug label, it shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval content. The factory-issued drug instructions and labels shall be replaced within 6 months after the filing of the supplementary application.
enterprises shall formulate a risk management plan, take effective measures to do a good job of cleaning up the use of ointment and safety issues of publicity and training, guide doctors to use drugs rationally. All production enterprises should carry out post-market research on this product and conduct in-depth research on the mechanism of new adverse reactions.
. Clinicians shall carefully read the revised contents of the broom ointment instructions and, when selecting medications, conduct adequate benefit/risk analysis in accordance with the newly revised instructions.
, a sweep ointment as a prescription drug, should be strictly under the guidance of the doctor to follow the doctor's instructions for medication, before the use of medicine should carefully read a sweep ointment instructions of the new revision.
, the State Pharmacopoeia Commission, in accordance with the revision of a sweeping ointment instructions, requires that the relevant contents of its drug standards be revised in accordance with the procedures, and organize the revision of the name of the drug.
this announcement.A sweep ointment instructions revised requirements First, should be added warning words, the following:
warning words: this product contains light powder, lead powder, red dan, long-term or large-term use can lead to lead, mercury accumulation poisoning., "functional treatment" should be deleted "child fetal poison", the content is as follows:
"functional treatment" to eliminate swelling, itching, pain relief. For eczema, yellow water sores and hemorrhoid diseases.III, "adverse reactions" items should include:
1. monitoring data show that the main adverse reactions of this product involving rash, itching, edema, pain, allergies and allergic reactions.
2. There are literature reports of lead poisoning in children.
3. There are literature reports on lead powder of this group of herbs, lead poisoning of children and adults caused by the external use of red dan, and mercury poisoning caused by light powder of group herbs., taboo items should include:
1. Allergic to this product and group ingredients disabled.
2. Liver and kidney inserosis are disabled.
3. It is prohibited for pregnant and lactating women.
4. Children are disabled., "Precautions" items should include:
1. This product is an external medicine, prohibited internal medicine.
2. The skin has decay, blisters, ulcers and obvious oozing.
. During use, care should be paid to observe the possible acute, chronic lead, mercury poisoning caused by various symptoms, signs and related clinical manifestations, regularly check blood lead, blood mercury and liver and kidney function.
4. Should not be used for long, not excessive use.
5. This product should be placed in a place that is out of the reach of the child. (State Administration of Food and Drug Administration)