Active Ingredient
Lidocaine 4%(W/W)
Komxsum Lidocaine Cream
FDA Label NDC 87786-055
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Komxsum Lidocaine Cream (NDC 87786-055). 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 ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Use
· Temporarily relieves pain and itching due to: minor burns, sunburn, insect bites, scrapes, minor skin irritations.
Warnings
For external use only.
Do Not Use
·on large areas of the body.
· on broken, blistered, or abraded skin.
· if allergic to local anesthetics such as lidocaine, benzocaine, or other "caine" derivatives.
When Using
·avoid contact with the eyes
·do not bandage tightly or use with heating pad
·use only as directed
Stop Use
·Condition worsens or does not improve within 7 days.
·Allergic reaction occurs to ingredients in this product.
·Symptoms being treated do not subside,or if redness or irritation develops.
Ask Doctor
·Condition worsens or does not improve within 7 days.
·Allergic reaction occurs to ingredients in this product.
·Symptoms being treated do not subside,or if redness or irritation develops.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
Directions
· Cleanse targeted skin area, pat dry.
· Apply a thin layer to the affected area, not more than 3–4 times daily.
Other Information
· Store at 15–30°C (59–86°F)
· Protect from excessive heat and direct sunlight
· Use only as directed
Inactive Ingredients
Water ,Carbomer 934 ,Propylene Glycol,Soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.
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