FDA.reportPublic FDA data

Fred's Burn Relief Spray with Aloe

Manufacturer
Fred’s Stores of Tennessee, Inc
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:47:18

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

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

Dosage and administration

shake can well for adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily for children under 2 years of age, ask a doctor to apply to face spray in palm of hand and gently apply

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with:

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

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

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

  • do not get into eyes
  • ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition gets worse
  • symptoms last more than 7 days or clears up and occurs again in 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

  • shake can well

  • for adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily

  • for children under 2 years of age, ask a doctor

  • to apply to face spray in palm of hand and gently apply

Other information

OTHER SAFETY INFORMATION

store between 20º and 25ºC (68º and 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis gel, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, tocopheryl acetate (vitamin E acetate), triethanolamine, simethicone, water

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fred's

Burn Relief Spray

LIDOCAINE 0.5%

External Analgesic

COOLING

Relieves pain and itching from sunburn, minor burns and insect bites

Cools, moisturizes and soothes sunburned skin

NET WT 4.5 OZ (127 g)

Burn Relief SprayBurn Relief Spray

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-37455315-374-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BUTANE6LV4FOR43RIACT
CARBOMER 934Z135WT9208IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPANET75W9911L6IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

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
2b5ca825-c205-542b-e063-6294a90a0c8f5c084a13-ab6e-487e-95b4-9f47e7c2854f2025-01-10WarningsExact identifier
spl set id: 5c084a13-ab6e-487e-95b4-9f47e7c2854f

Reported adverse events (FAERS/openFDA)#

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