FDA.reportPublic FDA data

Dragon Pain Numbing Roll-On

Manufacturer
Genomma Lab USA
Effective date
2021-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:40

Label at a glance#

ProductDragon Pain Numbing Roll-On
Active ingredientLidocaine hydrochloride
Label structure11 sections

Dosage and administration

use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Storage and handling

store at room temperature. close cap tightly after use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body, particularly over raw surfaces or blistered areas
  • on wounds or damaged skin

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes
  • do not apply tight bandages
  • do not apply a heating pad to treated skin
  • do not use in large quantities

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature.
  • close cap tightly after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Decolorized Aloe Barbadensis Leaf Juice, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl StearateSE, Phenoxyethanol, Steareth-21, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-994-3666

SPL UNCLASSIFIED SECTION

Distributed by
Genomma Lab USA, Inc.,
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 71 g Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

POMADA
DRAGON®

Lidocaine HCl 4%

PAIN NUMBING ROLL ON

MAX STRENGTH

NUMBS PAIN
FAST

HOURS OF
RELIEF

ODOR
FREE

KEEPS HANDS CLEAN!

BLOCKS PAIN
RECEPTORS

NO MESS
APPLICATOR!

NET WT 2.5 oz (71 g)

PRINCIPAL DISPLAY PANEL - 71 g Container Carton
PRINCIPAL DISPLAY PANEL - 71 g Container Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN1
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD1
1987647lidocaine hydrochloride 4 % Topical SolutionSY1

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
50066-411-022025-01-30C16284748780-12cef2736-6484-d83d-e063-dadaa90ab31fDragon ® Pain Numbing Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-411-02Dragon Pain Numbing Roll-On71 g in 1 CONTAINERLIQUID711
50066-411-02Dragon Pain Numbing Roll-On1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-411DRAGON PAIN NUMBING ROLL-ON (LIDOCAINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA]1Legacy NDC, 2 package rows20210727_65cbdda6-b555-49fb-86e7-ce458c64cae0.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-41150066-411-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine hydrochlorideV13007Z41AACTIR
Alcohol3K9958V90MIACT
Water059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ceteth-20 phosphate921FTA1500IACT
Steareth-2153J3F32P58IACT

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
45415c6f-3939-47fd-85c9-705fe1c3673465cbdda6-b555-49fb-86e7-ce458c64cae02021-07-26WarningsExact identifier
spl id: 45415c6f-3939-47fd-85c9-705fe1c36734
spl set id: 65cbdda6-b555-49fb-86e7-ce458c64cae0

Reported adverse events (FAERS/openFDA)#

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