Dragon Pain Relief
FDA Label NDC 50066-412

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Dragon Pain Relief (NDC 50066-412). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, allergy alert, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredients

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

Purpose

Topical analgesics

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Allergy Alert

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

Do Not Use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

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

When Using This Product

  • 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

  • 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

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

Otc - Keep Out Of Reach Of Children

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

  • 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

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

Inactive Ingredients

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

Questions Or Comments?

Call toll free 1 877 994 3666.

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

Principal Display Panel - 56.7 G Tube Carton

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)

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