Dragon with Arnical Pain Relief Gel 2 oz 5621 ZDP

Manufacturer
Genomma Lab USA Inc.
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:41:45

Label at a glance#

ProductDragon with Arnical Pain Relief
Active ingredientMENTHOL
Label structure14 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Menthol 4%.......................................................Topical analgesic

OTC - PURPOSE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • 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.

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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.

INDICATIONS & USAGE SECTION

Directions

  • 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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

56215621

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN9
415974menthol 0.04 MG/MG Topical GelSCD9
415974menthol 4 % Topical GelSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130650240056215GTIN-13: 0650240056215
EAN-13: 0650240056215
GTIN-12: 650240056215
UPC-A: 650240056215
GTIN storage (14 digits): 00650240056215
5621.1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-621-56Dragon with Arnical Pain Relief1 in 1 CARTONGEL19
50066-621-56Dragon with Arnical Pain Relief56.7 g in 1 TUBEGEL56.79

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-62150066-621-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-01-09full-release2026-06-01 00:52:14

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
Dragon with Arnical Pain ReliefMENTHOLGenomma Lab USA Inc.b4cbb7b6-cb71-9721-e053-2995a90a2b2c2025-10-31WarningsExact identifier
ndc (package): 50066-621-56
ndc (product): 50066-621
ndc11 (package): 50066062156
spl id: 427c82c9-9d22-cb4f-e063-6294a90a7881
spl set id: b4cbb7b6-cb71-9721-e053-2995a90a2b2c

Reported adverse events (FAERS/openFDA)#

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