Sunburn Pain Relief
FDA Label NDC 36800-883

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Top Care for the product Sunburn Pain Relief (NDC 36800-883). 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 for temporary relief of pain and itching due to, warnings, when using this product, stop use and ask a doctor if, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                             Purpose

Lidocaine Hydrochloride 0.5%                        External analgesic

Uses For Temporary Relief Of Pain And Itching Due To

  • sunburn
  • minor burns
  • insect bites
  • cuts
  • scrapes

Warnings

For external use only

When Using This Product

  • avoid contact with eyes. Rinse with water if contact occurs.

Stop Use And Ask A Doctor If

• symptoms last more than 7 days.

Directions

• adults and children 2 years of age and older: apply to affected area, not more than 3 to 4 times a day
• children under 2 years of age: consult a physician

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80,
Propylene Glycol, Triethanolamine, Water, Yellow 5

* Please review the disclaimer below.