PAIN RELIEF GEL-ROLL ON- lidocaine and menthol gel

PAIN RELIEF Gel-Roll On by

Drug Labeling and Warnings

PAIN RELIEF Gel-Roll On by is a Otc medication manufactured, distributed, or labeled by Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)

Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

Purpose

(Lidocaine) Topical Anesthetic

(Menthol) Topical Analgesic

Use

temporary relief of pain

Warnings

For external use only

Do not use

on large areas of the body or on cut, irritated or swollen skin not apply to wounds or damaged skin on puncture wounds for more than one week without consulting a doctor

When using this product

use only as directed. Read and follow all directions and warnings on this label do not allow contact with eyes and mucous membranes do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use do not use at the same time as other topical analgesics

Stop use if

condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur within a few days

Ask a doctor if

condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur within a few days

Flammable

keep away from fire or flame

If pregnant or breast-feeding

Ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children 12 over years:

apply a thin layer to affected area 6 to 8 hours, not to exceed 3 application in a 24 hour period

Children under 12 years of age: Consult a doctor

Inactive Ingredients

Aloe Vera Extract, Carbopol, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water

Questions or Comments

86-21-31166566

GENERAL PRECAUTIONS

Child-resistant packaging. Close cap tightly after use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF GEL-ROLL ON 
lidocaine and menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-373
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 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
WATER (UNII: 059QF0KO0R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-373-25	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/22/2022

Labeler - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(73557-373) , label(73557-373)