Active Ingredient
Lidocaine 5% w/w
Zmztuhua Numbing Cream
FDA Label NDC 87298-050
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 Hechuang Commercial Service Co.,ltd. for the product Zmztuhua Numbing Cream (NDC 87298-050). 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, inactive ingredients, use, warnings, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic
Inactive Ingredients
benzyl alcohol, calendula officinalis flower, carbomer 934, emu oil, lecithin (soybean), propylene glycol, alpha-tocopherol acetate, water
Use
Temporary Relief of Pain,Burning & Itching Associated with Hemorrhoids
■for the temporary relief of pain, burning, itching, soreness and discomfort associated with hemorrhoids and other anorectal disorders
Warnings
For external use only.
Allergy alert:
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.
Do not use
■if you are allergic to lidocaine or any ingredient in this product
Ask a doctor before use if
■you are pregnant or breast-feeding
When using this product
■avoid contact with eyes
■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
■do not use more than directed
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
■rectal bleeding occurs
■condition worsens or does not improve within 7 days
■allergic reaction occurs
■symptoms clear up and return within a few days
Otc - Keep Out Of Reach Of Children
NOTICE
For external use only. Use only as directed.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
■adults and children 12 years and older:
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 applying.
■apply externally to the affected area up to 6 times daily, or as directed by a doctor.
■children under 12 years of age: consult a doctor.
Other Information
Other information
■store at 20-25°℃ (68-77°F)
■protect from excessive heat
■tamper evident: do not use if carton is open or tube seal is broken or missing
Rems Administrative Information
DISTRIBUTED BY:
Linyi Houdaosheng Health Management Consulting Co., Ltd.
200 meters west of the intersection of Beiyuan Road and Dongyuemiao Street, Lanshan District, Linyi City, Shandong Province, China,
Postcode: 276000
[email protected]
Questions?
Questions?
Call 1-833-202-4518
Monday-Friday 9 AM-5 PM (EST)
Package Label.Principal Display Panel
Principal Display Panel (Label)
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