FDA.reportPublic FDA data

TopCare Burn Relief Spray

Manufacturer
Topco Associates LLC
Effective date
2026-09-23
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
daily-update
Hydrated at
2026-09-26 01:01:42

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

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

Dosage and administration

shake can well for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily for children under 2 years of age: consult 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 temporary relief of pain and itching associated with:

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

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Use only as directed. 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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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 clear up and occur 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 of age and older: apply to affected area not more than 3 to 4 times daily
  • for children under 2 years of age: consult 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 leaf juice, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerin, methylparaben, propane, propylene glycol, propylparaben, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, water

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care health

Burn Relief

Spray

LIDOCAINE 0.5%

EXTERNAL ANALGESIC

  • Relieves Pain & Itching from

Sunburn, Minor Burns & Insect Bites

  • Cools, Moisturizes & Soothes

Sunburned Skin

NET WT 4.5 OZ (127 g)

Burn relief sprayBurn relief spray

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/48zrp8Top Care_Burn Relief Spray_50-022TC-02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

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
36800-03136800-031-45

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
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BUTANE6LV4FOR43RIACT
CARBOMER 9404Q93RCW27EIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPANET75W9911L6IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-11-06full-release2026-06-01 01:42:38
112024-12-11full-release2026-06-01 00:42:26

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
42f4727d-b67d-acb7-e063-6394a90a04215faa1d39-12ce-4a65-8e53-0c040e9145402025-11-06WarningsExact identifier
spl set id: 5faa1d39-12ce-4a65-8e53-0c040e914540

Reported adverse events (FAERS/openFDA)#

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