Active Ingredient
Lidocaine 5% ......................................... Local anesthetic
Lidocaine Numbing Cream
FDA Label NDC 83602-311
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. for the product Lidocaine Numbing Cream (NDC 83602-311). 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, uses, warnings, when using this product, stop use ... if, ... ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic
Uses
·temporarily relieves local and anorectal itching and discomfort associated with hemorrhoids
·temporarily relieves pain, soreness, and burning associated with hemorrhoids
Warnings
For external use only
When Using This Product
·do not exceed the recommended daily dosage unless directed by a doctor
·do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use ... If
·bleeding occurs
·condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
·Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor promptly.
... Ask A Doctor If
• skin reactions such as redness, swelling, blistering or other discomfort occur
• symptoms persist for more than 7 days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over
·when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
·gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
·Apply externally to the affected area up to 6 times daily
Children under 12 years of age: consult a doctor
Other Information
·store at USP controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Aloe Vera Extract, Arnica Montana Flower Extract, Carbomer,Cetostearyl Alcohol, C10-18 Triglycerides, Dimethicone, Edetate Disodium, Ethylhexylglycerin, Glyceryl Mono- and Dipalmitostearate,Hydroxyacetophenone, Isopropyl Myristate, Polysorbate 60,
Propylene Glycol, Vitamin E, Water
Questions Or Comments:
Package Label.Principal Display Panel
311-36_jar (311 36 Jar)
311-36_box-jar (311 36 Box Jar)
311-49_bottle (311 49 Bottle)
311-49_box-bottle (311 49 Box Bottle)
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