CSI Capsaicin Pain Relieving Gel-Patch, 5 Patches

Pain Relieving Gel-Patch by

Drug Labeling and Warnings

Pain Relieving 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 RELIEVING GEL-PATCH- capsaicin 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 Capsaicin Pain Relieving Gel-Patch, 5 Patches

Active Ingredient

Capsaicin 0.025% w/w ...... Purpose: Topical anesthetic

Purpose

Topical analgesic

Uses

For temporary relief of minor aches & pains of muscles & joints associated with:

• simple backache
• arthritis
• stratins
• bruises
• sprains

Warnings

For external use only

Do not use

• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product

When using this product

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

Stop use and ask a doctor if

• Rash, itching or excessive skin irratation develops
• 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

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moiture

Inactive Ingredients

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Isopropyl Myristate, Polysorbate 80, PVP, Hydroxyacetophenone, Dihydroxyaluminum Aminoacetate, L-Tartaric Acid, Titanium Dioxide, Carboxymethylcellulose Sodium, Kaolin, Edetate Disodium.

Questions or Comments

86-21-31166566

Package label. Principal display panel

PAIN RELIEVING GEL-PATCH 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.00075 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)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POVIDONE K90 (UNII: RDH86HJV5Z)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-181-05	5 in 1 BOX	08/25/2022	12/30/2022
1	NDC: 73557-181-01	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	08/25/2022	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(73557-181) , label(73557-181)

Revised: 12/2022

Document Id: f1058f69-c79f-7df3-e053-2a95a90afe26

34390-5

Set id: e714c4e2-f314-31e0-e053-2995a90a1bcf

Version: 3

Effective Time: 20221230

 

Shanghai Chuang