DRAGON PAIN RELIEF- lidocaine patch

Dragon Pain Relief by

Drug Labeling and Warnings

Dragon 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

Lidocaine 4%................................................................Topical anesthetic

PURPOSE

Use

• temporarily relieves minor pain

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• more than 1 patch on your body at a time
• on cut, irritated or swollen skin
• at the same as other topical analgesics
• on puncture wounds
• for more than one week without consulting a doctor

WHEN USING

When using this product

• use only as directed. Read and follow all directions and wanrings.
• do not allow contact with the eyes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• discontinue use at least 1 hour before a bath or shower
• dispose of used patch in manner that always keep product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

STOP USE

Stop use and ask a doctor if

• condition worsens
• redness is present
• symptoms persist for more than 7 days or clear up and occur again within a few days
• irritation develops
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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

adults and children over 12 years:

• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
• carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
• once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
• use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

DOSAGE & ADMINISTRATION

Distributed by:

Genomma Lab USA, Inc.,

Houston, TX 77027

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRAGON PAIN RELIEF 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-224-05	5 in 1 CARTON	01/18/2019
1		1 in 1 POUCH; 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	01/18/2019

Labeler - Genomma Lab USA, Inc. (832323534)