Otc - Active Ingredient
Lidocaine 4%
Lidocaine Gel
FDA Label NDC 71888-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bellus Medical, Llc for the product Lidocaine (NDC 71888-102). 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 otc - active ingredient, inactive ingredient, dosage & administration, warnings, indications & usage, otc - purpose, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Xanthan Gum, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA.
Dosage & Administration
USES: For the temporary relief of discomfort and pain associated with
- Minor burns and skin irritations
- Minor cuts and scrapes
- Itching
DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.
Warnings
WARNINGS: For external use only. Avoid contact with the eyes.
DO NOT USE: In large quantities particularly over raw sources or blistered areas.
Indications & Usage
USES: For the temporary relief of discomfort and pain associated with
- Minor burns and skin irritations
- Minor cuts and scrapes
- Itching
DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.
Otc - Purpose
Topical Anesthetic
Otc - Keep Out Of Reach Of Children
Keep put of reach of children.
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