FDA.reportPublic FDA data

Redicare Burn Gel

Manufacturer
Redicare LLC
Effective date
2025-03-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:44

Label at a glance#

ProductRedicare Burn Gel
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

Temporary pain relief for minor burns

Dosage and administration

for adults and children 2 years and older: apply to affected area not more than 4 times daily children under 2: do not use, consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2.0%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief for minor burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • In large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water.

Stop use and ask doctor

OTC - STOP USE SECTION

if condition worsens or persists for more than 7 days or clears up and occurs 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

  • for adults and children 2 years and older: apply to affected area not more than 4 times daily
  • children under 2: do not use, consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • aloe vera
  • carbomer
  • germaben II
  • propylene glycol
  • purified water
  • menthol
  • triethanolamine
  • vitamin E acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REDICARE

BURN GEL

for minor burns, scalds & sunburn

WITH ALOE VERA FOR BEST RELIEF

3.5g / 1/8 oz.

NDC 71105-500-01

DRUG FACTS...

PacketPacket

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011852lidocaine HCl 2 % Topical GelPSN2
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD2
1011852lidocaine hydrochloride 2 % Topical JellySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71105-500-022025-03-05C16284748780-1ba0f9c33-3315-a910-e053-dadaa90a0b85Burn Gel USA
71105-500-022021-01-29C16284748780-1ba0f9c33-3315-a910-e053-dadaa90a0b85Burn Gel USA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71105-500-01Redicare Burn Gel3.3 g in 1 PACKETGEL3.32
71105-500-02Redicare Burn Gel15 in 1 BOXGEL152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71105-500REDICARE BURN GEL GEL [REDICARE LLC]2Current NDC, Legacy NDC, 2 package rows20250308_947ac362-acfb-3508-e053-2a95a90a2873.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71105-50071105-500-01, 71105-500-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
PROPYLENE GLYCOL6DC9Q167V3IACT
MENTHOLL7T10EIP3AIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
Redicare Burn GelREDICARE BURN GELRedicare LLC947ac362-acfb-3508-e053-2a95a90a28732025-03-05WarningsExact identifier
ndc (package): 71105-500-02
ndc (package): 71105-500-01
ndc (product): 71105-500
ndc11 (package): 71105050001
ndc11 (package): 71105050002
spl id: 2f9cfcad-603b-4de7-e063-6294a90a6172
spl set id: 947ac362-acfb-3508-e053-2a95a90a2873

Reported adverse events (FAERS/openFDA)#

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