FDA.reportPublic FDA data

Maximum Strength Burn Relief Aloe Gel

Manufacturer
Product Quest Mfg.
Effective date
2018-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:42

Label at a glance#

ProductMaximum Strength Burn Relief Aloe Gel Scherer Labs
Active ingredientLidocaine Hydrochloride
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                            Purpose

Lidocaine Hydrochloride - 4.00%      Topical analgesic

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of pain and itching
due to • sunburn • minor burns • insect bites
• minor cuts • scrapes • minor skin irritation

WARNINGS SECTION

Warnings
For external use only.
When using this product • avoid contact with
eyes. Rinse with water if contact occurs.
Stop use and ask doctor if • if symptoms persist
for more than 7 days.
Do not use in large quantities, particularly over raw
surfaces or blistered areas.

DOSAGE & ADMINISTRATION SECTION

Directions

• Adults and children 2 years and
older: apply to affected area not more than 3-4 times
a day. • Children under 2 years
of age: consult a physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf Extract, Avena
Sativa (Oat) Kernel Extract, Blue
1, Caprylyl Glycol, Chlorphenesin,
Dimethyl Isosorbide, Glycerin,
Hydroxyethylcellulose, Isopropyl
Alcohol, Phenoxyethanol,
Polysorbate 20, Propanediol,
Tocopheryl Acetate, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN1
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD1
1010077lidocaine hydrochloride 4 % Topical GelSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130727510006727GTIN-13: 0727510006727
EAN-13: 0727510006727
GTIN-12: 727510006727
UPC-A: 727510006727
GTIN storage (14 digits): 00727510006727		label.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64048-5002-42020-01-31C16284748780-19d75b9d0-d591-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64048-5002-4Maximum Strength Burn Relief Aloe GelScherer Labs118 mL in 1 BOTTLEGEL1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64048-5002MAXIMUM STRENGTH BURN RELIEF ALOE GEL SCHERER LABS (LIDOCAINE HYDROCHLORIDE 4.00%) GEL [PRODUCT QUEST MFG.]1Legacy NDC, 1 package rows20180529_54425e59-f0f7-41fb-ab0b-f449d5688baf.zip

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
64048-500264048-5002-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine HydrochlorideV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
OATZ6J799EAJKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
Caprylyl Glycol00YIU5438UIACT
ChlorphenesinI670DAL4SZIACT
Dimethyl IsosorbideSA6A6V432SIACT
GlycerinPDC6A3C0OXIACT
Isopropyl AlcoholND2M416302IACT
PhenoxyethanolHIE492ZZ3TIACT
Polysorbate 207T1F30V5YHIACT
Propanediol5965N8W85TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

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
25953ec6-bd39-4693-b246-8ba17156ae2154425e59-f0f7-41fb-ab0b-f449d5688baf2018-05-29WarningsExact identifier
spl id: 25953ec6-bd39-4693-b246-8ba17156ae21
spl set id: 54425e59-f0f7-41fb-ab0b-f449d5688baf

Reported adverse events (FAERS/openFDA)#

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