FDA.reportPublic FDA data

Dragon ® Pain Relief Gel

Manufacturer
Genomma Lab USA
Effective date
2020-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:51

Label at a glance#

ProductDragon Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

temporarily relieves the minor aches and pains of muscles and joints associated with: sprains simple backache arthritis strains bruises

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 wash hands after use with cool water

Storage and handling

store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves the minor aches and pains of muscles and joints associated with:
    • sprains
    • simple backache
    • arthritis
    • strains
    • bruises

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
  • with other ointments, creams, sprays or liniments

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

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
  • excessive skin irritation occurs

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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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
  • wash hands after use with cool water

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Arnica Montana Flower, Camphor, Carbomer, FD&C Blue No. 1, FD&C Yellow No. 5, Isopropyl Alcohol, Methylparaben, Polysorbate 80, Potassium sorbate, Purified water, Tocopheryl Acetate, Trolamine

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-994-3666
Monday to Friday, 8 am to 6 pm Central time.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDICINAL SCENT

GEL
DRAGON®

WITH ARNICA

PAIN RELIEF GEL

Menthol 4% topical pain reliever

INFUSED WITH
ARNICA

Non-greasy gel formula

Relieves muscle, back and joint pain,
bruises, strains and sprains.

COOLING EFFECT

Fast Acting

NET. WT 2.0 oz (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN1
415974menthol 0.04 MG/MG Topical GelSCD1
415974menthol 4 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-410-022022-01-28C16284748780-1d6a99b39-cdde-a426-e053-dadaa90af4c2Dragon ® Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-410-02Dragon Pain Relief56.7 g in 1 TUBEGEL56.71
50066-410-02Dragon Pain Relief1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-410DRAGON PAIN RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [GENOMMA LAB USA]1Legacy NDC, 2 package rows20201210_9206462e-3bf5-4cf8-8bb3-d6de5911e5d1.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-41050066-410-02

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
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT

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
e557bd5d-273e-49a0-9485-2557f5f9e2309206462e-3bf5-4cf8-8bb3-d6de5911e5d12020-12-08WarningsExact identifier
spl id: e557bd5d-273e-49a0-9485-2557f5f9e230
spl set id: 9206462e-3bf5-4cf8-8bb3-d6de5911e5d1

Reported adverse events (FAERS/openFDA)#

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