CSI LIDOCAINE&MENTHOL PAIN RELIEF GEL-PATCH, 5 Patches

PAIN RELIEF Gel-Patch by

Drug Labeling and Warnings

PAIN RELIEF Gel-Patch 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]

PAIN RELIEF GEL-PATCH- lidocaine and menthol patch 
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CSI LIDOCAINE&MENTHOL PAIN RELIEF GEL-PATCH, 5 Patches

Active Ingredient

Lidocaine 4% w/w ...... Purpose: Topical anesthetic

Menthol 1% w/w ...... Purpose: Topical analgesic

Purposes

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Uses

For temporary relief of pain

Warnings

For external use only

When using this product:

• Use only as directed
• Avoid contact with the eyes, mucous membranes or rashes
• Do not bandage tightly

Do not use:

• More than 1 patch at a time
• On wounds or damaged skin
• For more than one week without consulting a doctor
• If you are allergic to any ingredients of this product

Stop use and ask a doctor if:

• Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Condition worsen
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

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

Adult and Children 12 years of age and over:

• Clean and dry affected area
• Remove film from patch and apply to the skin (see illustration)
• 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 12 years of age: Consult a doctor

Inactive Ingredients

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Polysorbate 80, Mineral oil, Polyvinylpyrrolidone K90, Hydroxyacetophenone, L(+)-Tartaric Acid, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide

Questions or Comments

86-21-31166566

Other information

• Store at 68-77℉ (20-25℃)
• Store in a cool dry place away from direct sunlight

Package label. Principal display panel

PAIN RELIEF GEL-PATCH 
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-173
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g  in 3 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.12 g  in 3 g

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

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-173-05	5 in 1 BOX	05/11/2022	12/30/2022
1	NDC: 73557-173-01	3 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/11/2022	12/30/2022

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(73557-173) , label(73557-173)

Revised: 12/2022

Document Id: f1058468-7d62-6650-e053-2a95a90a914e

34390-5

Set id: db6f111b-399b-62aa-e053-2995a90a65b9

Version: 5

Effective Time: 20221230

 

Shanghai Chuang