LIDOCAINE PAIN RELIEF GEL-PATCH- lidocaine kit

Lidocaine Pain Relief Gel-Patch by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4%

PURPOSE

Topical Anesthetic

INDICATIONS & USAGE

Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shouldcrs,elbows.

WARNINGS

For external use only

DO NOT USE

· more than 1 patch on your body at a time or with other topical anesthetics at the same time

· on wounds or damaged skin

· with a heating pad or device

· with other ointments, creams, sprays, or liniments

· 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

· dispose of used patch in manner that always keeps product away from children and 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

· localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering

· condition worsens

· symptoms persist for more than 7 days

· symptoms clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

if swallowed accidentally , get medical help orcontact with Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Adults and Children above 12 years old:

· Clean and dry the affected area.

· Tear off the protective film and apply the exposed part of the patch to the affected area.

· Carefully remove remaining film while pressing the patch firmly on the skin.

· 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 age of 12:Consult a doctor

INACTIVE INGREDIENT

Dihydroxyaluminum Aminoacetate Anhydrous
Glycerin
Kaolin
Methylparaben
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Propylparaben
PVP
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF GEL-PATCH 
lidocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84165-006

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-006-06	6 in 1 BOX	04/14/2025
1		1 in 1 BAG; Type 0: Not a Combination Product
2	NDC: 84165-006-07	7 in 1 BOX	04/14/2025
2		1 in 1 BAG; Type 0: Not a Combination Product
3	NDC: 84165-006-08	8 in 1 BOX	04/14/2025
3		1 in 1 BAG; Type 0: Not a Combination Product
4	NDC: 84165-006-09	9 in 1 BOX	04/14/2025
4		1 in 1 BAG; Type 0: Not a Combination Product
5	NDC: 84165-006-10	10 in 1 BOX	04/14/2025
5		1 in 1 BAG; Type 0: Not a Combination Product
6	NDC: 84165-006-11	11 in 1 BOX	04/14/2025
6		1 in 1 BAG; Type 0: Not a Combination Product
7	NDC: 84165-006-12	12 in 1 BOX	04/14/2025
7		1 in 1 BAG; Type 0: Not a Combination Product
8	NDC: 84165-006-13	13 in 1 BOX	04/14/2025
8		1 in 1 BAG; Type 0: Not a Combination Product
9	NDC: 84165-006-14	14 in 1 BOX	04/14/2025
9		1 in 1 BAG; Type 0: Not a Combination Product
10	NDC: 84165-006-15	15 in 1 BOX	04/14/2025
10		1 in 1 BAG; Type 0: Not a Combination Product
11	NDC: 84165-006-16	16 in 1 BOX	04/14/2025
11		1 in 1 BAG; Type 0: Not a Combination Product
12	NDC: 84165-006-17	17 in 1 BOX	04/14/2025
12		1 in 1 BAG; Type 0: Not a Combination Product
13	NDC: 84165-006-18	18 in 1 BOX	04/14/2025
13		1 in 1 BAG; Type 0: Not a Combination Product
14	NDC: 84165-006-19	19 in 1 BOX	04/14/2025
14		1 in 1 BAG; Type 0: Not a Combination Product
15	NDC: 84165-006-20	20 in 1 BOX	04/14/2025
15		1 in 1 BAG; Type 0: Not a Combination Product
16	NDC: 84165-006-21	21 in 1 BOX	04/14/2025
16		1 in 1 BAG; Type 0: Not a Combination Product
17	NDC: 84165-006-22	22 in 1 BOX	04/14/2025
17		1 in 1 BAG; Type 0: Not a Combination Product
18	NDC: 84165-006-23	23 in 1 BOX	04/14/2025
18		1 in 1 BAG; Type 0: Not a Combination Product
19	NDC: 84165-006-24	24 in 1 BOX	04/14/2025
19		1 in 1 BAG; Type 0: Not a Combination Product
20	NDC: 84165-006-25	25 in 1 BOX	04/14/2025
20		1 in 1 BAG; Type 0: Not a Combination Product
21	NDC: 84165-006-26	26 in 1 BOX	04/14/2025
21		1 in 1 BAG; Type 0: Not a Combination Product
22	NDC: 84165-006-27	27 in 1 BOX	04/14/2025
22		1 in 1 BAG; Type 0: Not a Combination Product
23	NDC: 84165-006-28	28 in 1 BOX	04/14/2025
23		1 in 1 BAG; Type 0: Not a Combination Product
24	NDC: 84165-006-29	29 in 1 BOX	04/14/2025
24		1 in 1 BAG; Type 0: Not a Combination Product
25	NDC: 84165-006-30	30 in 1 BOX	04/14/2025
25		1 in 1 BAG; Type 0: Not a Combination Product
26	NDC: 84165-006-31	31 in 1 BOX	04/14/2025
26		1 in 1 BAG; Type 0: Not a Combination Product
27	NDC: 84165-006-32	32 in 1 BOX	04/14/2025
27		1 in 1 BAG; Type 0: Not a Combination Product
28	NDC: 84165-006-33	33 in 1 BOX	04/14/2025
28		1 in 1 BAG; Type 0: Not a Combination Product
29	NDC: 84165-006-34	34 in 1 BOX	04/14/2025
29		1 in 1 BAG; Type 0: Not a Combination Product
30	NDC: 84165-006-35	35 in 1 BOX	04/14/2025
30		1 in 1 BAG; Type 0: Not a Combination Product
31	NDC: 84165-006-36	36 in 1 BOX	04/14/2025
31		1 in 1 BAG; Type 0: Not a Combination Product
32	NDC: 84165-006-37	37 in 1 BOX	04/14/2025
32		1 in 1 BAG; Type 0: Not a Combination Product
33	NDC: 84165-006-38	38 in 1 BOX	04/14/2025
33		1 in 1 BAG; Type 0: Not a Combination Product
34	NDC: 84165-006-39	39 in 1 BOX	04/14/2025
34		1 in 1 BAG; Type 0: Not a Combination Product
35	NDC: 84165-006-40	40 in 1 BOX	04/14/2025
35		1 in 1 BAG; Type 0: Not a Combination Product
36	NDC: 84165-006-41	41 in 1 BOX	04/14/2025
36		1 in 1 BAG; Type 0: Not a Combination Product
37	NDC: 84165-006-42	42 in 1 BOX	04/14/2025
37		1 in 1 BAG; Type 0: Not a Combination Product
38	NDC: 84165-006-43	43 in 1 BOX	04/14/2025
38		1 in 1 BAG; Type 0: Not a Combination Product
39	NDC: 84165-006-44	44 in 1 BOX	04/14/2025
39		1 in 1 BAG; Type 0: Not a Combination Product
40	NDC: 84165-006-45	45 in 1 BOX	04/14/2025
40		1 in 1 BAG; Type 0: Not a Combination Product
41	NDC: 84165-006-46	46 in 1 BOX	04/14/2025
41		1 in 1 BAG; Type 0: Not a Combination Product
42	NDC: 84165-006-47	47 in 1 BOX	04/14/2025
42		1 in 1 BAG; Type 0: Not a Combination Product
43	NDC: 84165-006-48	48 in 1 BOX	04/14/2025
43		1 in 1 BAG; Type 0: Not a Combination Product
44	NDC: 84165-006-49	49 in 1 BOX	04/14/2025
44		1 in 1 BAG; Type 0: Not a Combination Product
45	NDC: 84165-006-50	50 in 1 BOX	04/14/2025
45		1 in 1 BAG; Type 0: Not a Combination Product
46	NDC: 84165-006-51	51 in 1 BOX	04/14/2025
46		1 in 1 BAG; Type 0: Not a Combination Product
47	NDC: 84165-006-52	52 in 1 BOX	04/14/2025
47		1 in 1 BAG; Type 0: Not a Combination Product
48	NDC: 84165-006-53	53 in 1 BOX	04/14/2025
48		1 in 1 BAG; Type 0: Not a Combination Product
49	NDC: 84165-006-54	54 in 1 BOX	04/14/2025
49		1 in 1 BAG; Type 0: Not a Combination Product
50	NDC: 84165-006-55	55 in 1 BOX	04/14/2025
50		1 in 1 BAG; Type 0: Not a Combination Product
51	NDC: 84165-006-56	56 in 1 BOX	04/14/2025
51		1 in 1 BAG; Type 0: Not a Combination Product
52	NDC: 84165-006-57	57 in 1 BOX	04/14/2025
52		1 in 1 BAG; Type 0: Not a Combination Product
53	NDC: 84165-006-58	58 in 1 BOX	04/14/2025
53		1 in 1 BAG; Type 0: Not a Combination Product
54	NDC: 84165-006-59	59 in 1 BOX	04/14/2025
54		1 in 1 BAG; Type 0: Not a Combination Product
55	NDC: 84165-006-60	60 in 1 BOX	04/14/2025
55		1 in 1 BAG; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BAG	1 g
Part 2	0 BAG	1 g
Part 3	0 BAG	1 g

Part 1 of 3

LIDOCAINE PAIN RELIEF GEL-PATCH 
lidocaine patch

Product Information
Item Code (Source)	NDC: 84165-107
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE K90 (UNII: RDH86HJV5Z)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-107-01	9 g in 1 BAG; 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	04/16/2025

Part 2 of 3

LIDOCAINE PAIN RELIEF GEL-PATCH 
lidocaine patch

Product Information
Item Code (Source)	NDC: 84165-002
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
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
KAOLIN (UNII: 24H4NWX5CO)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE K90 (UNII: RDH86HJV5Z)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-002-01	21 g in 1 BAG; 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	04/16/2025

Part 3 of 3

LIDOCAINE PAIN RELIEF GEL-PATCH 
lidocaine patch

Product Information
Item Code (Source)	NDC: 84165-005
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
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
KAOLIN (UNII: 24H4NWX5CO)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE K90 (UNII: RDH86HJV5Z)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-005-01	12 g in 1 BAG; 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	04/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/14/2025

Labeler - Guangzhou Zhupuyou E-commerce Co., Ltd (418214143)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		418214143	manufacture(84165-006)