Lidocream 10
FDA Label NDC 52763-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Golden Touch Llc for the product Lidocream 10 (NDC 52763-101). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine 10% w/w
Purpose
Topical Anesthetic
Otc - 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.
Indications & Usage
Uses For the temporary relief of pain and itching due to anorectal disorders
Warnings
For external use only
When using this product • avoid contact with eyes • do not put in rectum • do not exceed recommended dosage unless directed by a doctor
Stop use and ask a doctor if: • allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • rectal bleeding occurs • redness, irritation, swelling, pain or other symptoms develop or increase
Dosage & Administration
Directions • Adults: 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 upto 6 times daily • Children under 12 years of age: consult a doctor
Inactive Ingredient
Inactive Ingredients Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water.
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