LIDOCAINE PAIN RELIEVE GEL-PATCH- pain relieve gel-patch patch

Lidocaine Pain Relieve Gel-Patch by

Drug Labeling and Warnings

Lidocaine Pain Relieve Gel-Patch by is a Otc medication manufactured, distributed, or labeled by Henan Kangdi Medical Devices Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

LIDOCAINE 4%

Purpose

Topical Analgesic

Use

For temporary relief of pain

Warnings

For external use only

Do not use

■ more than 1 patch at a time
■ on wounds or damaged skin

■ with a heating pad

■ if you are allergic to any ingredients of this product

When Using

■ use only as directed
■ avoid contact with the eyes, mucous membranes, or rashes
■ do not bandage tightly

Stop Use

■ localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
■ condition worsen
■ symptoms persist far more than 7 days
■ symptoms clear up and occur again within a few days

Ask Doctor

lf pregnant or breast-feeding

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Centerright away.

Directions

Adult and children 12 years of age and over:
■ clean and dry affected area
■ remove film from patch and apply to the skin (see illustration)
■ apply 1 patch at a time to affected area, not more than 3 to 4 times daily
■ remove patch from the skin after at most 8-hour application
■ Children under 12 years of age: consult a doctor

Other information

■ Avoid storing product in direct sunlight
■ Protect product from excessive moisture

Inactive ingredients

Dihydroxyaluminum Aminoacetate,Edetate Disodium,Glycerin,Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral oil.Polysorbate 80, Polyacrylic Acid,Polyvinylpyrrolidone K90,Propylene Glycol, Sodium Polyacrylate,Titanium Dioxide,Water.

Questions

Healthpatchofficial@gmail.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEVE GEL-PATCH 
pain relieve gel-patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69561-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
GLYCERIN (UNII: PDC6A3C0OX)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE K90 (UNII: RDH86HJV5Z)
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69561-005-01	10 in 1 BOX	07/27/2024
1		12 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 69561-005-02	18 in 1 BOX	07/27/2024
2		12 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 69561-005-03	30 in 1 BOX	07/27/2024
3		12 g in 1 PATCH; 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	07/27/2024

Labeler - Henan Kangdi Medical Devices Co., Ltd (421288241)

Establishment
Name	Address	ID/FEI	Business Operations
Henan Kangdi Medical Devices Co., Ltd		421288241	manufacture(69561-005)