Active Ingredient
Lidocaine HCl 3%
Lidocaine 3% Cream
FDA Label NDC 59088-241
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Lidocaine 3% (NDC 59088-241). 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, when using this product:, stop use and ask a doctor if, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
For the temporarily relief of pain and itching associated with:
•minor burns •sunburn •minor cuts •scrapes •insect bites •minor skin irritations •rashes due to poison ivy, poison oak, or poison sumac.
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 A Doctor If
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a licensed healthcare practitioner.
Otc - Keep Out Of Reach Of Children
• Keep this and all other drugs out of the reach of children.
Directions:
• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: do not use, consult a licensed healthcare practitioner.
Other Information
• Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]
Inactive Ingredients:
Aqua (Purified Water), Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Sodium Phosphate.
* Please review the disclaimer below.
