Ebsl-5 Kit
FDA Label NDC 59898-140

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Water-jel Technologies for the product Ebsl-5 (NDC 59898-140). 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, do not use, when using this product, stop use and ask a doctor if, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine HCl 2.0 %

Purpose

External analgesic

Uses

for the temporary relief of pain associated with minor burns

Warnings

For external use only

Directions

  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • spread a thick even layer over affected skin
  • children under 2 years of age: consult a doctor

Other Information

  • store at room temperature
  • do not use packeet if opened or torn
  • you may report a serious adverse reaction to this product to 800-275-3433

Inactive Ingredients

triethanolamine, meleleuca alternifolia (tea tree) leaf oil, glycerin, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, carbomer, octoxynol-9, acrylates C/10-30 alkyl acrylate, disodium EDTA

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