FDA.reportPublic FDA data

DCH Pain Relief Roll-On

Manufacturer
Derma Care Research Labs, LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:11

Label at a glance#

ProductDCH Pain Relief Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical Analgesic

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of pain and itching.

WARNINGS SECTION

For external use only. Flammable--keep away from fire or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.

Stop use and ask a doctor if the condition worsens, 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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

INDICATIONS & USAGE SECTION

Adults and children 12 years and older: apply to the affected area, not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, SD Alcohol 40, Steareth-21, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN2
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD2
1010077lidocaine hydrochloride 4 % 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
72839-087-02DCH Pain Relief Roll-On1 in 1 CARTONGEL12
72839-087-02DCH Pain Relief Roll-On71 g in 1 BOTTLEGEL712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-087DCH PAIN RELIEF ROLL-ON (LIDOCAINE HCL 4%) GEL [DERMA CARE RESEARCH LABS, LLC]2Current NDC, 2 package rows20241222_fda35d37-f36e-efc8-e053-6294a90a2bb8.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-08772839-087-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARETH-2153J3F32P58IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETETH-20 PHOSPHATE921FTA1500IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
EDETATE DISODIUM7FLD91C86KIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
METHYLPARABENA2I8C7HI9TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT
DIMETHICONE 200RGS4T2AS00IACT
ALCOHOL3K9958V90MIACT

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 Pain Relief Roll-OnLIDOCAINE HCL 4%Derma Care Research Labs, LLCfda35d37-f36e-efc8-e053-6294a90a2bb82024-12-19WarningsExact identifier
ndc (package): 72839-087-02
ndc (product): 72839-087
ndc11 (package): 72839008702
spl id: 29a4c95d-6ce1-955f-e063-6294a90a1846
spl set id: fda35d37-f36e-efc8-e053-6294a90a2bb8

Reported adverse events (FAERS/openFDA)#

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