FDA.reportPublic FDA data

DCH Burn Relief Gel, Lidocaine HCl 0.5%

Manufacturer
Derma Care Research Labs, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:11

Label at a glance#

ProductDCH Burn Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 0.5%

OTC - PURPOSE SECTION

External Analgesic.

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.

WARNINGS SECTION

For external use only.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: consult a physician. To apply to face, squeeze into palm of hand and gently apply.

INACTIVE INGREDIENT SECTION

Water, Glycerin, Isopropyl Alcohol, Aloe Barbadensis Leaf Extract, Menthol, Propylene Glycol, Polysorbate 80, Triethanolamine, Carbomer, Disodium EDTA, Blue 1, Yellow 5, Diazolidinyl Urea.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

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
72839-955-08DCH Burn Relief227 g in 1 BOTTLE, PLASTICGEL2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-955DCH BURN RELIEF (LIDOCAINE HCL) GEL [DERMA CARE RESEARCH LABS, LLC]2Current NDC, 1 package rows20241222_ff227154-cf3b-9796-e053-6294a90a5535.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-95572839-955-08

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MENTHOLL7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9404Q93RCW27EIACT
POLYSORBATE 806OZP39ZG8HIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
DCH Burn ReliefLIDOCAINE HCLDerma Care Research Labs, LLCff227154-cf3b-9796-e053-6294a90a55352024-12-20WarningsExact identifier
ndc (package): 72839-955-08
ndc (product): 72839-955
ndc11 (package): 72839095508
spl id: 29b74830-5479-c90b-e063-6294a90a4e72
spl set id: ff227154-cf3b-9796-e053-6294a90a5535

Reported adverse events (FAERS/openFDA)#

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