Drug Facts - Active Ingredient
Lidocaine 5%
Lidocaine Roll-on Gel
FDA Label NDC 73581-023
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 Roll-on (NDC 73581-023). 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 drug facts - active ingredient, purpose, uses, warnings, pregnancy or breast-feeding warning, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anorectal (hemorrhoidal)
Uses
- Helps relieve 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. Do not put this product into the rectum by using your fingers or any mechanical device or applicator.
- Do not 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 and ask a doctor 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.
Pregnancy Or Breast-Feeding Warning
If pregnant or breast-feeding, ask a health professional before use
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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. Apply externally to the affected area up to 6 times daily or after each bowel movement.
Children under 12 years of age: consult a doctor.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polysorbate 60, Sodium Hydroxide, Water (Aqua).
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