Bio-scriptives Lidum Topical Analgesic
FDA Label NDC 60608-017

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 Topical Analgesic (NDC 60608-017). 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, purpose, uses, warnings, stop use and ask doctor if:, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Local Analgesic

Uses

For the temporary relief of pain and itching due to:

■ minor burns

■ minor skin irritations

■ scrapes

■ minor cuts

■ sunburn

■ insect bites

Warnings

For external use only

When using this product

■ avoid contact with the eyes

■ do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use And Ask Doctor If:

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: Consult a doctor.

Inactive Ingredients

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

Package And Label Images

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