CSI, DEEP PAIN RELIEF, Lidocaine & Menthol & Methyl salicylate, 5 Patches

DEEP PAIN RELIEF by

Drug Labeling and Warnings

DEEP PAIN RELIEF 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]

DEEP PAIN RELIEF- lidocaine, menthol, methyl salicylate patch 
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

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CSI, DEEP PAIN RELIEF, Lidocaine & Menthol & Methyl salicylate, 5 Patches

Active Ingredient

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

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

Methyl salicylate 2% w/w ...... Purpose: Topical analgesic

Purpose

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Topical analgesic (Methyl salicylate)

Uses

Temporarily relieves mild to moderate aches and pains of muscle and joints associated with: · muscle soreness · strains · sprains · arthritis · simple backache · muscle stiffness · bruises

Warnings

For external use only

Stomach bleeding warning

This product contains a NSAID, which may cause stomach bleeding. The chance is smaill but higher if you · are aged 60 or older · have had stomach ulcers or bleeding problems · take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others) · take a blood thinning (anticoagulant) or steroidal drug · have three or more alcoholic drinks every day while using this product · take more or for a longer time than directed.

Do not use

· More than one patch on your body at a time · On cut, irritated or swollen skin · On puncture wounds · If you are allergic to any active or inactive ingredients · If pouch is damaged or opened.

When using this product

· Use only as directed · Read and follow all directions and warnings · Do not allow to contact with the eyes · Do not use at the same time as other topical analgesics · Do not bandage tightly or apply local heat (such as heating pads) to the area of use · Do not microwave · Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor if

· Condition worsens · Redness is present · Irritation develops · Symptoms persist for more than 7 days or clear up and occur again within a few days · You experience signs of skin injury, such as pain, swelling or blistering where the product was applied · Stomach pain or upset gets worse or lasts · You feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding).

If pregnant or breastfeeding

Ask a health professional before use.

Keep out of reach of children and pets

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

Directions

Adults, or children over the age of 12: Clean and dry affected area. Apply sticky side of patch to affected area and leave in place for 8 hours. If pain lasts after using the first patch, a second patch may be applied. Only use one patch at a time. Do not use more than 2 patches per day. Wash hands with soap and water after applying or removing patch. Reseal pouch containing unused patches immediately after each use.

Children under 12 years of age: Do not use.

Other information

· Store at 68℉-77℉ (20℃-25℃)

· Store in a clean, dry place without direct sunlight. Protect from excessive moisture.

· Some individuals may not experience pain relief until several minutes or hours after applying the patch.

Inactive Ingredients

Arnica Montana Flower Extract, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-Tartaric Acid, Mineral Oil, Polyacrylic Acid, Propylene Glycol, Polysorbate 80, PVP, Sodium Polyacrylate, Titanium Dioxide, Water.

Questions or Comments

86-21-31166566

Package label. Principal display panel

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DEEP PAIN RELIEF 
lidocaine, menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73557-165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.01 g  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73557-165-051 in 1 BOX02/06/202311/13/2023
15 in 1 POUCH
111 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/06/202311/13/2023
Labeler - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(73557-165) , label(73557-165)

Revised: 11/2023
 
Shanghai Chuang

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