Unburn Spray
FDA Label NDC 59898-510

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 Unburn (NDC 59898-510). 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 2.5%

Purpose

External analgesic

Uses

for the temporary relief of pain associated with:

  • sunburn
  • minor burns
  • minor skin irritations
  • insect bites

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
  • children under 2 years of age: consult a doctor

Other Information

  • store at 15 o to 25 oC (59 o to 77 oF)
  • do not freeze
  • you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive Ingredients

acrylates/C20-30 alkyl acrylate crosspolymer, aloe, caprylyl glycol, carbomer, chlorophenesin, edetate disodium, glyceryl-7 stearate,  octoxynol-9, polysorbate 20, phenoxyethanol, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate

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