PLANTAR FASCIITIS PAIN RELIEF GEL-PATCH- lidocaine, menthol patch

Plantar Fasciitis Pain Relief Gel-Patch by

Drug Labeling and Warnings

Plantar Fasciitis 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%
MENTHOL 1%

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 withother 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 keepsproduct away from children and pets. Used patchesstill contain the drug product that can produce seriousadverse 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
econdition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few 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 exposedpart of the patch to the affected area.
Carefully remove remaining film while pressingthe patch fimmly on the skin.
Apply 1 patch at a time to affected area, not morethan 3 to 4 times daily.
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

PLANTAR FASCIITIS PAIN RELIEF GEL-PATCH 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84165-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product	05/07/2025
2	NDC: 84165-007-05	5 in 1 BOX	05/07/2025
2	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
3	NDC: 84165-007-06	6 in 1 BOX	05/07/2025
3	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
4	NDC: 84165-007-07	7 in 1 BOX	05/07/2025
4	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
5	NDC: 84165-007-08	8 in 1 BOX	05/07/2025
5	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
6	NDC: 84165-007-09	9 in 1 BOX	05/07/2025
6	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
7	NDC: 84165-007-10	10 in 1 BOX	05/07/2025
7	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
8	NDC: 84165-007-11	11 in 1 BOX	05/07/2025
8	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
9	NDC: 84165-007-12	12 in 1 BOX	05/07/2025
9	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
10	NDC: 84165-007-13	13 in 1 BOX	05/07/2025
10	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
11	NDC: 84165-007-14	14 in 1 BOX	05/07/2025
11	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
12	NDC: 84165-007-15	15 in 1 BOX	05/07/2025
12	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
13	NDC: 84165-007-16	16 in 1 BOX	05/07/2025
13	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
14	NDC: 84165-007-17	17 in 1 BOX	05/07/2025
14	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
15	NDC: 84165-007-18	18 in 1 BOX	05/07/2025
15	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
16	NDC: 84165-007-19	19 in 1 BOX	05/07/2025
16	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
17	NDC: 84165-007-20	20 in 1 BOX	05/07/2025
17	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
18	NDC: 84165-007-21	21 in 1 BOX	05/07/2025
18	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
19	NDC: 84165-007-22	22 in 1 BOX	05/07/2025
19	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
20	NDC: 84165-007-23	23 in 1 BOX	05/07/2025
20	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
21	NDC: 84165-007-24	24 in 1 BOX	05/07/2025
21	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
22	NDC: 84165-007-25	25 in 1 BOX	05/07/2025
22	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
23	NDC: 84165-007-26	26 in 1 BOX	05/07/2025
23	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
24	NDC: 84165-007-27	27 in 1 BOX	05/07/2025
24	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
25	NDC: 84165-007-28	28 in 1 BOX	05/07/2025
25	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
26	NDC: 84165-007-29	29 in 1 BOX	05/07/2025
26	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
27	NDC: 84165-007-30	30 in 1 BOX	05/07/2025
27	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
28	NDC: 84165-007-31	31 in 1 BOX	05/07/2025
28	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
29	NDC: 84165-007-32	32 in 1 BOX	05/07/2025
29	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
30	NDC: 84165-007-33	33 in 1 BOX	05/07/2025
30	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
31	NDC: 84165-007-34	34 in 1 BOX	05/07/2025
31	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
32	NDC: 84165-007-35	35 in 1 BOX	05/07/2025
32	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
33	NDC: 84165-007-36	36 in 1 BOX	05/07/2025
33	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
34	NDC: 84165-007-37	37 in 1 BOX	05/07/2025
34	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
35	NDC: 84165-007-38	38 in 1 BOX	05/07/2025
35	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
36	NDC: 84165-007-39	39 in 1 BOX	05/07/2025
36	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
37	NDC: 84165-007-40	40 in 1 BOX	05/07/2025
37	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
38	NDC: 84165-007-41	41 in 1 BOX	05/07/2025
38	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
39	NDC: 84165-007-42	42 in 1 BOX	05/07/2025
39	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
40	NDC: 84165-007-43	43 in 1 BOX	05/07/2025
40	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
41	NDC: 84165-007-44	44 in 1 BOX	05/07/2025
41	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
42	NDC: 84165-007-45	45 in 1 BOX	05/07/2025
42	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
43	NDC: 84165-007-46	46 in 1 BOX	05/07/2025
43	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
44	NDC: 84165-007-47	47 in 1 BOX	05/07/2025
44	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
45	NDC: 84165-007-48	48 in 1 BOX	05/07/2025
45	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
46	NDC: 84165-007-49	49 in 1 BOX	05/07/2025
46	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
47	NDC: 84165-007-50	50 in 1 BOX	05/07/2025
47	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
48	NDC: 84165-007-51	51 in 1 BOX	05/07/2025
48	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
49	NDC: 84165-007-52	52 in 1 BOX	05/07/2025
49	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
50	NDC: 84165-007-53	53 in 1 BOX	05/07/2025
50	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
51	NDC: 84165-007-54	54 in 1 BOX	05/07/2025
51	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
52	NDC: 84165-007-55	55 in 1 BOX	05/07/2025
52	NDC: 84165-007-01	6 g in 1 BAG; Type 0: Not a Combination Product
53	NDC: 84165-007-56	56 in 1 BOX	05/07/2025
53	NDC: 84165-007-01	6 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	05/07/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(84165-007)