PAIN RELIEF GEL-PATCH- lidocaine, menthol patch

PAIN RELIEF Gel-Patch by

Drug Labeling and Warnings

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]

SPL UNCLASSIFIED SECTION

PAIN RELIEF Gel-Patch

ACTIVE INGREDIENT

Lidocaine 4%
Menthol 1%

PURPOSE

Topical Anesthetic

INDICATIONS & USAGE

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

WARNINGS

For external 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 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 ofthe patch to the the affected area.
Carefully remove remaining film while pressing the patchfirmly on the skin.
Remove patch from the skin after at most 8-hourapplication.
Children under age of 12: Consult a doctor

INACTIVE INGREDIENT

Dihydroxyaluminum Aminoacetate
Edetate Disodium
Glycerin
Hydroxyacetophenone
Kaolin
Mineral Oil
Polyacrylic Acid
Polysorbate 80
PolyvinylPyrrolidone
Propylene Glycol
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF GEL-PATCH 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84165-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.01 g  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
POVIDONE K90 (UNII: RDH86HJV5Z)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product	09/24/2024
2	NDC: 84165-104-05	5 in 1 BOX	09/24/2024
2	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
3	NDC: 84165-104-06	6 in 1 BOX	09/24/2024
3	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
4	NDC: 84165-104-07	7 in 1 BOX	09/24/2024
4	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
5	NDC: 84165-104-08	8 in 1 BOX	09/24/2024
5	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
6	NDC: 84165-104-09	9 in 1 BOX	09/24/2024
6	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
7	NDC: 84165-104-10	10 in 1 BOX	09/24/2024
7	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
8	NDC: 84165-104-11	11 in 1 BOX	09/24/2024
8	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
9	NDC: 84165-104-12	12 in 1 BOX	09/24/2024
9	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
10	NDC: 84165-104-13	13 in 1 BOX	09/24/2024
10	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
11	NDC: 84165-104-14	14 in 1 BOX	09/24/2024
11	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
12	NDC: 84165-104-15	15 in 1 BOX	09/24/2024
12	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
13	NDC: 84165-104-16	16 in 1 BOX	09/24/2024
13	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
14	NDC: 84165-104-17	17 in 1 BOX	09/24/2024
14	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
15	NDC: 84165-104-18	18 in 1 BOX	09/24/2024
15	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
16	NDC: 84165-104-19	19 in 1 BOX	09/24/2024
16	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
17	NDC: 84165-104-20	20 in 1 BOX	09/24/2024
17	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
18	NDC: 84165-104-21	21 in 1 BOX	09/24/2024
18	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
19	NDC: 84165-104-22	22 in 1 BOX	09/24/2024
19	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
20	NDC: 84165-104-23	23 in 1 BOX	09/24/2024
20	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
21	NDC: 84165-104-24	24 in 1 BOX	09/24/2024
21	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
22	NDC: 84165-104-25	25 in 1 BOX	09/24/2024
22	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
23	NDC: 84165-104-26	26 in 1 BOX	09/24/2024
23	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
24	NDC: 84165-104-27	27 in 1 BOX	09/24/2024
24	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
25	NDC: 84165-104-28	28 in 1 BOX	09/24/2024
25	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
26	NDC: 84165-104-29	29 in 1 BOX	09/24/2024
26	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
27	NDC: 84165-104-30	30 in 1 BOX	09/24/2024
27	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
28	NDC: 84165-104-31	31 in 1 BOX	09/24/2024
28	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
29	NDC: 84165-104-32	32 in 1 BOX	09/24/2024
29	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
30	NDC: 84165-104-33	33 in 1 BOX	09/24/2024
30	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
31	NDC: 84165-104-34	34 in 1 BOX	09/24/2024
31	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
32	NDC: 84165-104-35	35 in 1 BOX	09/24/2024
32	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
33	NDC: 84165-104-36	36 in 1 BOX	09/24/2024
33	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
34	NDC: 84165-104-37	37 in 1 BOX	09/24/2024
34	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
35	NDC: 84165-104-38	38 in 1 BOX	09/24/2024
35	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
36	NDC: 84165-104-39	39 in 1 BOX	09/24/2024
36	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
37	NDC: 84165-104-40	40 in 1 BOX	09/24/2024
37	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
38	NDC: 84165-104-41	41 in 1 BOX	09/24/2024
38	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
39	NDC: 84165-104-42	42 in 1 BOX	09/24/2024
39	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
40	NDC: 84165-104-43	43 in 1 BOX	09/24/2024
40	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
41	NDC: 84165-104-44	44 in 1 BOX	09/24/2024
41	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
42	NDC: 84165-104-45	45 in 1 BOX	09/24/2024
42	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
43	NDC: 84165-104-46	46 in 1 BOX	09/24/2024
43	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
44	NDC: 84165-104-47	47 in 1 BOX	09/24/2024
44	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
45	NDC: 84165-104-48	48 in 1 BOX	09/24/2024
45	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
46	NDC: 84165-104-49	49 in 1 BOX	09/24/2024
46	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
47	NDC: 84165-104-50	50 in 1 BOX	09/24/2024
47	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
48	NDC: 84165-104-51	51 in 1 BOX	09/24/2024
48	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
49	NDC: 84165-104-52	52 in 1 BOX	09/24/2024
49	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
50	NDC: 84165-104-53	53 in 1 BOX	09/24/2024
50	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
51	NDC: 84165-104-54	54 in 1 BOX	09/24/2024
51	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
52	NDC: 84165-104-55	55 in 1 BOX	09/24/2024
52	NDC: 84165-104-01	12 g in 1 BAG; Type 0: Not a Combination Product
53	NDC: 84165-104-56	56 in 1 BOX	09/24/2024
53	NDC: 84165-104-01	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	09/24/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(84165-104)