Purpose
Anorectal (hemorrhoidal) cream
Lidocaine Cream
FDA Label NDC 73581-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Lidocaine (NDC 73581-022). 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 purpose, uses, warnings, for external use only, when using this product, stop use, ask a doctor or pharmacist before use if you are, allergy alert, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
■ Helps relieve the local itching and discomfort in the perianal area
■ For the temporary relief of pain, irritation or burning
■ Temporarily shrinks hemorrhoidal tissue.
Warnings
____________________________________________________________
For External Use Only
Do not ■ exceed the recommended daily dosage unless directed by a
doctor ■ put this product into the rectum by using your fingers or any
mechanical device or applicator. ■ use this product if you have heart
disease, high blood pressure, thyroid disease, diabetes, or difficulty
in urination due to enlargement of the prostate gland unless directed
by a doctor
When Using This Product
■ if the condition worsens or does not improve,
within 7 days consult a doctor ■in case of bleeding consult a doctor promptly.
Stop Use
■ If the symptoms being treated do not subside or if redness,
irritation, swelling, pain, or other symptoms develop or increase.
Ask A Doctor Or Pharmacist Before Use If You Are
■ presently taking a prescription drug for high blood pressure or depression.
Allergy Alert
■ Certain persons can develop allergic reactions to ingredients in this product. taking a prescription drug for high blood
pressure or depression.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding,
ask a health professional before use.
Directions
Adults: ■ When practical, cleanse the affected area with mild
soap and warm water and rinse by patting or blotting with an appropriate
cleansing pad ■ Gently dry by patting or blotting with toilet tissue or
a soft cloth before application of this product. ■ Children under 12
years of age: consult a doctor. ■ Apply externally to the affected area
up to 6 times daily or after each bowel movement.
Other Information
■ Protect the product in this container from excessive
heat and direct sun.
Inactive Ingredients
Carbomer, Cetearyl Alcohol, Disodium EDTA,
Ethylhexylglycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Isopropyl
Myristate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid,
Tocopherol, Triethanolamine, Water (Aqua)
Questions?
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