DRAGON WITH ARNICAL PAIN RELIEF- menthol gel

Dragon with Arnical Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

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

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only

DO NOT 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
• with other ointments, creams, sprays or liniments

ASK DOCTOR

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

WHEN USING

When using this product

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

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

Other information

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

INACTIVE INGREDIENT

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

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRAGON WITH ARNICAL PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-621
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-621-56	1 in 1 CARTON	11/23/2020
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 Drug	M017	11/23/2020

Labeler - Genomma Lab USA Inc. (832323534)