CSI Nonivamide 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: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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CSI Nonivamide 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: 73557-182
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NONIVAMIDE (UNII: S846B891OR) (NONIVAMIDE - UNII:S846B891OR)	NONIVAMIDE	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: 73557-182-05	5 in 1 BOX	09/05/2022	12/30/2022
1	NDC: 73557-182-01	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
unapproved drug other		09/05/2022	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(73557-182) , label(73557-182)

Revised: 12/2022

Document Id: f10598ba-f8cd-8355-e053-2a95a90ab33c

34390-5

Set id: e79b9d38-6bb5-3e58-e053-2995a90abccf

Version: 2

Effective Time: 20221230

 

Shanghai Chuang