FDA.reportPublic FDA data

Dragon ® Pain Relief Cream

Manufacturer
Genomma Lab USA
Effective date
2021-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:56

Label at a glance#

ProductDragon Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR, (-)-, methyl salicylate
Label structure11 sections

Indications and uses

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

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 between 20° and 25° C (68° and 77° F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%, Menthol 10%, Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical analgesics

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Allergy alert

SPL UNCLASSIFIED SECTION

  • If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

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

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

  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness is present or irritation or rash develops
  • conditions worsen 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.

If swallowed, get medical help or contact a Poison Control Center immediately (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

Other information

STORAGE AND HANDLING SECTION

  • Store between 20° and 25° C (68° and 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1 877 994 3666.

Monday to Friday 8:00 am – 6:00 pm CST

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

POMADA
DRAGON®
ULTRA STRENGTH

PAIN RELIEF CREAM

FAST RELIEF OF MUSCLE,
BACK AND JOINT PAIN

Deep Penetrating
Fast Acting Relief

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
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN1
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD1
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-412-022025-01-30C16284748780-12cef2736-b249-d83d-e063-dadaa90ab31fDragon ® Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-412-02Dragon Pain Relief1 in 1 CARTONCREAM11
50066-412-02Dragon Pain Relief56.7 g in 1 TUBECREAM56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-412DRAGON PAIN RELIEF (MENTHOL, UNSPECIFIED FORM, CAMPHOR, (-)-, AND METHYL SALICYLATE) CREAM [GENOMMA LAB USA]1Legacy NDC, 2 package rows20210817_40c1a66f-a21f-4f81-a072-3bdd1a612ad8.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-41250066-412-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR, (-)-213N3S8275ACTIB
methyl salicylateLAV5U5022YACTIB
glyceryl monostearate230OU9XXE4IACT
Water059QF0KO0RIACT
Polysorbate 806OZP39ZG8HIACT
sorbitan monooleate06XEA2VD56IACT
stearic acid4ELV7Z65APIACT
ethylparaben14255EXE39IACT

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
010331fb-8731-4ec9-ab95-9110e69886e540c1a66f-a21f-4f81-a072-3bdd1a612ad82021-08-16WarningsExact identifier
spl id: 010331fb-8731-4ec9-ab95-9110e69886e5
spl set id: 40c1a66f-a21f-4f81-a072-3bdd1a612ad8

Reported adverse events (FAERS/openFDA)#

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