LIDOCAINE PAIN RELIEF GEL-PATCH- lidocaine patch

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, Foshan Aqua Gel Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Lidocaine Pain Relief Gel-Patch

ACTIVE INGREDIENT

Lidocaine 4%

PURPOSE

Topical Anesthetic

INDICATIONS & USAGE

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

WARNINGS

For extemal use only

DO NOT USE

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

STOP USE

skin reactions such as redness,swelling, blistering or other discomfort occur
symptoms persist for more than 7 days

KEEP OUT OF REACH OF CHILDREN

lf 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
Remove patch from the skin after at most 8-hour application
Children under age of 12:Consult a doctor

INACTIVE INGREDIENT

Glycerin
Sodium Polyacrylate
Water
Methylparaben
Propylparaben
Dihydroxyaluminum aminoacetate
Tartaric acid
PVP
Polysorbate 80
Kaolin
Titanium Dioxide
Propylene glycol
Polyacrylic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF GEL-PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84165-106
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
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYLPARABEN (UNII: A2I8C7HI9T)
TARTARIC ACID (UNII: W4888I119H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
PVP (UNII: FZ989GH94E)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product	01/09/2025
2	NDC: 84165-106-05	5 in 1 BOX	01/09/2025
2	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
3	NDC: 84165-106-06	6 in 1 BOX	01/09/2025
3	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
4	NDC: 84165-106-07	7 in 1 BOX	01/09/2025
4	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
5	NDC: 84165-106-08	8 in 1 BOX	01/09/2025
5	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
6	NDC: 84165-106-09	9 in 1 BOX	01/09/2025
6	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
7	NDC: 84165-106-10	10 in 1 BOX	01/09/2025
7	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
8	NDC: 84165-106-11	11 in 1 BOX	01/09/2025
8	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
9	NDC: 84165-106-12	12 in 1 BOX	01/09/2025
9	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
10	NDC: 84165-106-13	13 in 1 BOX	01/09/2025
10	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
11	NDC: 84165-106-14	14 in 1 BOX	01/09/2025
11	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
12	NDC: 84165-106-15	15 in 1 BOX	01/09/2025
12	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
13	NDC: 84165-106-16	16 in 1 BOX	01/09/2025
13	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
14	NDC: 84165-106-17	17 in 1 BOX	01/09/2025
14	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
15	NDC: 84165-106-18	18 in 1 BOX	01/09/2025
15	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
16	NDC: 84165-106-19	19 in 1 BOX	01/09/2025
16	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
17	NDC: 84165-106-20	20 in 1 BOX	01/09/2025
17	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
18	NDC: 84165-106-21	21 in 1 BOX	01/09/2025
18	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
19	NDC: 84165-106-22	22 in 1 BOX	01/09/2025
19	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
20	NDC: 84165-106-23	23 in 1 BOX	01/09/2025
20	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
21	NDC: 84165-106-24	24 in 1 BOX	01/09/2025
21	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
22	NDC: 84165-106-25	25 in 1 BOX	01/09/2025
22	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
23	NDC: 84165-106-26	26 in 1 BOX	01/09/2025
23	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
24	NDC: 84165-106-27	27 in 1 BOX	01/09/2025
24	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
25	NDC: 84165-106-28	28 in 1 BOX	01/09/2025
25	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
26	NDC: 84165-106-29	29 in 1 BOX	01/09/2025
26	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
27	NDC: 84165-106-30	30 in 1 BOX	01/09/2025
27	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
28	NDC: 84165-106-31	31 in 1 BOX	01/09/2025
28	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
29	NDC: 84165-106-32	32 in 1 BOX	01/09/2025
29	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
30	NDC: 84165-106-33	33 in 1 BOX	01/09/2025
30	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
31	NDC: 84165-106-34	34 in 1 BOX	01/09/2025
31	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
32	NDC: 84165-106-35	35 in 1 BOX	01/09/2025
32	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
33	NDC: 84165-106-36	36 in 1 BOX	01/09/2025
33	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
34	NDC: 84165-106-37	37 in 1 BOX	01/09/2025
34	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
35	NDC: 84165-106-38	38 in 1 BOX	01/09/2025
35	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
36	NDC: 84165-106-39	39 in 1 BOX	01/09/2025
36	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
37	NDC: 84165-106-40	40 in 1 BOX	01/09/2025
37	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
38	NDC: 84165-106-41	41 in 1 BOX	01/09/2025
38	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
39	NDC: 84165-106-42	42 in 1 BOX	01/09/2025
39	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
40	NDC: 84165-106-43	43 in 1 BOX	01/09/2025
40	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
41	NDC: 84165-106-44	44 in 1 BOX	01/09/2025
41	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
42	NDC: 84165-106-45	45 in 1 BOX	01/09/2025
42	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
43	NDC: 84165-106-46	46 in 1 BOX	01/09/2025
43	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
44	NDC: 84165-106-47	47 in 1 BOX	01/09/2025
44	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
45	NDC: 84165-106-48	48 in 1 BOX	01/09/2025
45	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
46	NDC: 84165-106-49	49 in 1 BOX	01/09/2025
46	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
47	NDC: 84165-106-50	50 in 1 BOX	01/09/2025
47	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
48	NDC: 84165-106-51	51 in 1 BOX	01/09/2025
48	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
49	NDC: 84165-106-52	52 in 1 BOX	01/09/2025
49	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
50	NDC: 84165-106-53	53 in 1 BOX	01/09/2025
50	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
51	NDC: 84165-106-54	54 in 1 BOX	01/09/2025
51	NDC: 84165-106-01	11 g in 1 BAG; Type 0: Not a Combination Product
52	NDC: 84165-106-55	55 in 1 BOX	01/09/2025
52	NDC: 84165-106-01	11 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	01/09/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.		529128763	manufacture(84165-106)