Select Brand Burn Relief
FDA Label NDC 15127-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Brand Distributors for the product Select Brand Burn Relief (NDC 15127-002). 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, otc - 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

Active Ingredient

Lidocaine HCL 0.50%

Purpose

Topical Anesthetic

Uses

  • temporary relief of pain and itching
  • helps relieve and soothes pain from sunburn, minor burns,cuts,scrapes, skin irritations and insect bites

Warnings

For external use only

When Using This Product

  • avoid contact with 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.
  • if symptoms clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed get medical help or contact Poison Control Center immediately.

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

Principal Display Panel

Select brandthe lower price name brandBURN RELIEFALOE VERA GELwithLIDOCAINECOOLS SUNBURN PAINNET WT 8 OZ( 227g)

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