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, 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, shoulders,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 or contact 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 patch

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

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	03/28/2025
2	NDC: 84165-002-03	3 in 1 BOX	03/28/2025
2	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
3	NDC: 84165-002-04	4 in 1 BOX	03/28/2025
3	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
4	NDC: 84165-002-05	5 in 1 BOX	03/28/2025
4	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
5	NDC: 84165-002-06	6 in 1 BOX	03/28/2025
5	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
6	NDC: 84165-002-07	7 in 1 BOX	03/28/2025
6	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
7	NDC: 84165-002-08	8 in 1 BOX	03/28/2025
7	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
8	NDC: 84165-002-09	9 in 1 BOX	03/28/2025
8	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
9	NDC: 84165-002-10	10 in 1 BOX	03/28/2025
9	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
10	NDC: 84165-002-11	11 in 1 BOX	03/28/2025
10	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
11	NDC: 84165-002-12	12 in 1 BOX	03/28/2025
11	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
12	NDC: 84165-002-13	13 in 1 BOX	03/28/2025
12	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
13	NDC: 84165-002-14	14 in 1 BOX	03/28/2025
13	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
14	NDC: 84165-002-15	15 in 1 BOX	03/28/2025
14	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
15	NDC: 84165-002-16	16 in 1 BOX	03/28/2025
15	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
16	NDC: 84165-002-17	17 in 1 BOX	03/28/2025
16	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
17	NDC: 84165-002-18	18 in 1 BOX	03/28/2025
17	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
18	NDC: 84165-002-19	19 in 1 BOX	03/28/2025
18	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
19	NDC: 84165-002-20	20 in 1 BOX	03/28/2025
19	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
20	NDC: 84165-002-21	21 in 1 BOX	03/28/2025
20	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
21	NDC: 84165-002-22	22 in 1 BOX	03/28/2025
21	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
22	NDC: 84165-002-23	23 in 1 BOX	03/28/2025
22	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
23	NDC: 84165-002-24	24 in 1 BOX	03/28/2025
23	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
24	NDC: 84165-002-25	25 in 1 BOX	03/28/2025
24	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
25	NDC: 84165-002-26	26 in 1 BOX	03/28/2025
25	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
26	NDC: 84165-002-27	27 in 1 BOX	03/28/2025
26	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
27	NDC: 84165-002-28	28 in 1 BOX	03/28/2025
27	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
28	NDC: 84165-002-29	29 in 1 BOX	03/28/2025
28	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
29	NDC: 84165-002-30	30 in 1 BOX	03/28/2025
29	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
30	NDC: 84165-002-31	31 in 1 BOX	03/28/2025
30	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
31	NDC: 84165-002-32	32 in 1 BOX	03/28/2025
31	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
32	NDC: 84165-002-33	33 in 1 BOX	03/28/2025
32	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
33	NDC: 84165-002-34	34 in 1 BOX	03/28/2025
33	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
34	NDC: 84165-002-35	35 in 1 BOX	03/28/2025
34	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
35	NDC: 84165-002-36	36 in 1 BOX	03/28/2025
35	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
36	NDC: 84165-002-37	37 in 1 BOX	03/28/2025
36	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
37	NDC: 84165-002-38	38 in 1 BOX	03/28/2025
37	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
38	NDC: 84165-002-39	39 in 1 BOX	03/28/2025
38	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
39	NDC: 84165-002-40	40 in 1 BOX	03/28/2025
39	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
40	NDC: 84165-002-41	41 in 1 BOX	03/28/2025
40	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
41	NDC: 84165-002-42	42 in 1 BOX	03/28/2025
41	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
42	NDC: 84165-002-43	43 in 1 BOX	03/28/2025
42	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
43	NDC: 84165-002-44	44 in 1 BOX	03/28/2025
43	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
44	NDC: 84165-002-45	45 in 1 BOX	03/28/2025
44	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
45	NDC: 84165-002-46	46 in 1 BOX	03/28/2025
45	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
46	NDC: 84165-002-47	47 in 1 BOX	03/28/2025
46	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
47	NDC: 84165-002-48	48 in 1 BOX	03/28/2025
47	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
48	NDC: 84165-002-49	49 in 1 BOX	03/28/2025
48	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
49	NDC: 84165-002-50	50 in 1 BOX	03/28/2025
49	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
50	NDC: 84165-002-51	51 in 1 BOX	03/28/2025
50	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
51	NDC: 84165-002-52	52 in 1 BOX	03/28/2025
51	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
52	NDC: 84165-002-53	53 in 1 BOX	03/28/2025
52	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
53	NDC: 84165-002-54	54 in 1 BOX	03/28/2025
53	NDC: 84165-002-01	21 g in 1 BAG; Type 0: Not a Combination Product
54	NDC: 84165-002-55	55 in 1 BOX	03/28/2025
54	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	03/28/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(84165-002)