FDA.reportPublic FDA data

Premier Solutions Burn Relief Spray

Manufacturer
Premier Brands of America Inc.
Effective date
2026-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-21 05:10:09

Label at a glance#

ProductBurn Relief
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

for temporary relief of pain and itching associated with: sunburn minor cuts scrapes minor burns insect bites minor skin irritations

Dosage and administration

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: do not use, consult a doctor to apply to face, spray in palm of hand and gently apply

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain and itching associated with:

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

Warnings

WARNINGS SECTION

For external use only.

Extremely Flammable:

SAFE HANDLING WARNING SECTION

Keep away from fire, sparks, and heated surfaces. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

OTC - WHEN USING SECTION

  • avoid spraying in the eyes
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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: do not use, consult a doctor
  • to apply to face, spray in palm of hand and gently apply

Other information

OTHER SAFETY INFORMATION

  • store between 20° and 25°C (68° and 77°F)
  • shake can well before use

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, butane, propane, propylene glycol, aloe barbadensis leaf juice, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium edta, glycerin, methylparaben, propylparaben, simethicone, tocopheryl acetate, triethanolamine.

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

premier
solutions

BURN
RELIEF
Spray
LIDOCAINE 0.5%/
EXTERNAL ANALGESIC

ALCOHOL-FREE

Relieves pain & itching

from sunburn, minor

burns & insect bites

Cools, moisturizes &
soothes sunburned skin

NET WT. 4.5 OZ. (127g)

cartoncarton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-91456104-914-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
BUTANE6LV4FOR43RIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHANOLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
METHYLPARABENA2I8C7HI9TIACT
PROPANET75W9911L6IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsExact identifier
ndc (package): 56104-914-01
ndc (product): 56104-914
ndc11 (package): 56104091401
spl id: 560c29d7-28ba-6410-e063-6394a90ab90f
spl set id: 560c29cc-2453-5d14-e063-6394a90a844f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.