Active Ingredient
Lidocaine 4%(W/W)
Dermfree Lidocaine 4% Numbing Topical Anorectal Cream
FDA Label NDC 87786-029
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 Dermfree Lidocaine 4% Numbing Topical Anorectal Cream (NDC 87786-029). 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
Pregnant or breastfeeding, ask a health professional before use.
if there is any allergic reaction to this product. In case of accidental overdose, get medical help, or contact the Poison Control Center immediately.
When Using
Avoid contact with eyes.
Only take the recommended daily dosage unless otherwise instructed by a doctor.
Some individuals may experience allergic reactions to the ingredients contained in this product.
Never put it into the rectum by using the finger or any medical device.
Stop Use
Pregnant or breastfeeding, ask a health professional before use.
if there is any allergic reaction to this product. In case of accidental overdose, get medical help, or contact the Poison Control Center immediately.
Ask Doctor
If discomfort persists for 7 days.The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.
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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