Active Ingredient
Lidocaine HCl 2%
Lidoease 2% Gel
FDA Label NDC 59088-221
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 Lidoease 2% (NDC 59088-221). 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, 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
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
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 or older: Apply externally to the affected area up to 3-4 times daily.
■ Children under 2 years: do not use, consult a doctor.
Other Information
■ Store at USP controlled room temperature 20° to 25°C (68° to 77°F)
Inactive Ingredients:
Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide.
Lidoease™ 2% Gel
Label (Label)
* Please review the disclaimer below.
