Sunburn Relief Gel
FDA Label NDC 55910-177

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Sunburn Relief (NDC 55910-177). 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, use, warnings, when using this product, do not use, stop use and ask a doctor if, keep out of 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 0.5%

Purpose

External Analgesic

Use

for the temporary 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

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 of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Inactive Ingredients

water, propylene glycol, glycerin, Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5

Other

This product is not manufactured or distributed by Bayer, distributor of Solaraine Cool Aloe Burn Relief Formula

Satisfaction

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE 

GOODLETTSVILLE, TN 37072

100 % Satisfction Guaranteed! (888)309-9030

Principal Display Panel

DS|health

Compare to Solarcaine

SUNBURN RELIEF

PAIN 

RELIEVING

GEL

with ALOE

Helps relieve the pain,

discomfort and itchiness

resulting from sunburn

NET WT 8 OZ (226 g)

Image Description (Mm3)

Image Description (Mm3)

* Please review the disclaimer below.