DRAGON PAIN RELIEF- menthol, unspecified form gel 
Genomma Lab USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dragon® Pain Relief Gel

Drug Facts

Active ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

Warnings

For external use only

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

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

When using this product

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

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

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

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

Directions

Other information

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

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

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
DRAGON PAIN RELIEF 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-410-021 in 1 CARTON11/12/2020
156.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34811/12/2020
Labeler - Genomma Lab USA (832323534)

Revised: 12/2020
Document Id: e557bd5d-273e-49a0-9485-2557f5f9e230
Set id: 9206462e-3bf5-4cf8-8bb3-d6de5911e5d1
Version: 1
Effective Time: 20201208
 
Genomma Lab USA