Bio-scriptives Lidum Hemorroidal (anorectal)
FDA Label NDC 60608-016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bio-scriptives, Inc. for the product Bio-scriptives Lidum Hemorroidal (anorectal) (NDC 60608-016). 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, uses, warnings, stop use and consult a doctor if:, directions, inactive ingredients, package and lidum images, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses

■ For the temporary relief of local discomfort associated with anorectal disorders

■ For the temporary relief of pain, soreness, and burning.

Warnings

For external use only.

When using this product ■ 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.

Stop Use And Consult A Doctor If:

■ condition worsens or does not improve within 7 days ■ bleeding occurs ■ allergic reaction occurs ■ redness, irritation, swelling, pain or other symptoms develop or increase

Directions

■ Children under 12 years of age: consult a doctor. ■ 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 up to 6 times daily.

Inactive Ingredients

Aloe, Water, Cholesterol, Isopropyl Mysristate, Aqua, Caprylic/Capric Triglyceride, Propylene Glycol, Hydrogenated Phosphatidylcholine, Glyceryl Stearate, PEG-100 Stearate, Arginine HCI, Ethyl Oleate, Propylene Glycol, Tocophersolan, Cetyl Alcohol, Triethanolamine, Xanthan Gum, Tocopherol, Allantoin, Aloe Barbadensis Leaf, Methylisothiazolinone, Methyl Nicotinate

Package And Lidum Images

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