PAIN RELIEVING GEL-PATCH- lidocaine patch

Pain Relieving Gel-Patch by

Drug Labeling and Warnings

Pain Relieving Gel-Patch by is a Otc medication manufactured, distributed, or labeled by Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4% ...... Purpose: Topical Anesthetic

Purpose

Topical Anesthetic

Uses

For temporary relief of pain

Warnings

For external use only

Ask a doctor if:

• localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persists for more than 7 days
• Symptoms clear up and occur again within a few days

When using this product

• Use only as directed
• Avoid contact with the eyes, mucous membranes or rashed
• Do not bandage tightly

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

Stop use if:

• localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persists for more than 7 days
• Symptoms clear up and occur again within a few days

Pregnancy or breast feeding

If pregnant or breastfeeding, 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 right 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

Dosage forms & strengths

This is a strip, patch dosage form.

The active ingredient strength is 4% w/w.

One patch one time, no more than 8 hours one time.

Inactive ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water

Questions or Comments?

1 646-223-0128 · Lu.FDAmanage@gmail.com

Other information

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

Package label. Principal display panel

INGREDIENTS AND APPEARANCE

PAIN RELIEVING GEL-PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE K90 (UNII: RDH86HJV5Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-157-05	5 in 1 BOX	12/30/2022
1	NDC: 73557-157-01	12 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 73557-157-15	15 in 1 BOX	01/09/2024
2	NDC: 73557-157-01	12 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 73557-157-18	18 in 1 BOX	01/09/2024
3	NDC: 73557-157-01	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	12/30/2022

Labeler - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(73557-157) , label(73557-157)