LIDOCAINE PAIN RELIEF GEL ROLL-ON- lidocaine gel

Lidocaine Pain Relief Gel Roll-On by

Drug Labeling and Warnings

Lidocaine Pain Relief Gel Roll-On 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, Topical Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only

DO NOT USE

on wounds or on irritated or damaged skin
with a heating pad or device
with other ointments,creams, sprays, orliniments
if your 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
do not expose the area to local heat or to direct sunlight

STOP USE

skin reactions such as redness,swelling blistering or other discomfort occur
condition worsens or symptoms persist formore than 7 days
symptoms clear up and occur again within afew days
redness is present or excessive skin irritation occurs

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:
apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily
massage until thoroughly absorbed into skin
wash hands thoroughly with soap and waterafter each use
children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

.ALPHA.-TOCOPHEROL, D-
Aloe Vera Extract
Carbomer
Isopropyl myristate
Lavender Oil
Phenoxyethanol
Polysorbate 80
Propylene Glycol
Tartaric acid
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF GEL ROLL-ON 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84165-003
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 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
CARBOMER (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-003-01	1 in 1 BOX	03/28/2025
1		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 84165-003-02	2 in 1 BOX	03/28/2025
2		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 84165-003-03	3 in 1 BOX	03/28/2025
3		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 84165-003-04	4 in 1 BOX	03/28/2025
4		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 84165-003-05	5 in 1 BOX	03/28/2025
5		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 84165-003-06	6 in 1 BOX	03/28/2025
6		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 84165-003-07	7 in 1 BOX	03/28/2025
7		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 84165-003-08	8 in 1 BOX	03/28/2025
8		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 84165-003-09	9 in 1 BOX	03/28/2025
9		73 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 84165-003-10	10 in 1 BOX	03/28/2025
10		73 mL in 1 BOTTLE; 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(84165-003)