FDA.reportPublic FDA data

MyDerm Pain Reliever Aloe Gel Lidocaine HCI 0.5% (IS0021)

Manufacturer
Medline Industries | Inspec Solutions LLC.
Effective date
2026-05-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:59:05

Label at a glance#

ProductMyDerm Aloe and Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine ............. 0.5%

OTC - PURPOSE SECTION

Lidocaine 0.5% ............. Pain Reliever

INDICATIONS & USAGE SECTION

Temporary relief of pain and itching due to

- sunburn - minor burn - insect bites - minor cuts - scraps

WARNINGS SECTION

Warnings

For external use only

When using this product keep out of eyes

Rinse with warter to remove

OTC - STOP USE SECTION

Sop use and ask a doctor

system persist for more than 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Direction

Adults and children 2 years and older: aooly to affected area not more that 3-4 times a day

Children under 2 years of age: consult a physician.

INACTIVE INGREDIENT SECTION


Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Reliever ALOE GEL Lidocain HCI 0.5%Pain Reliever ALOE GEL Lidocain HCI 0.5%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN2
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD2
1011849lidocaine hydrochloride 0.5 % Topical GelSY2

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-130680750881625GTIN-13: 0680750881625
EAN-13: 0680750881625
GTIN-12: 680750881625
UPC-A: 680750881625
GTIN storage (14 digits): 00680750881625		203612-022519.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-037-09MyDerm Aloe and Lidocaine592 mL in 1 BOTTLE, PLASTICGEL5922

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
53329-03753329-037-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MENTHOLL7T10EIP3AIACT
PROPYLENE GLYCOL 2-STEARATE5317AOR1RXIACT
TROLAMINE SALICYLATEH8O4040BHDIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 1342809Y72KV36IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DISODIUM HEDTAKME849MC7AIACT
POLYSORBATE 806OZP39ZG8HIACT
FD&C YELLOW NO. 5 FREE ACID6TP696149NIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
ndc (package): 53329-037-09
ndc (product): 53329-037
ndc11 (package): 53329003709
spl id: 52bef461-4f91-2f1e-e063-6394a90aa0cd
spl set id: fdfd4388-cd27-467b-959b-249a49ea5cf6

Reported adverse events (FAERS/openFDA)#

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