DRAGON PAIN RELIEF- menthol, unspecified form gel

Dragon Pain Relief by

Drug Labeling and Warnings

Dragon Pain Relief by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

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

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

• 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

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

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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

DRAGON PAIN RELIEF 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-410-02	1 in 1 CARTON	11/12/2020
1		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	11/12/2020

Labeler - Genomma Lab USA (832323534)