HOT PAIN RELIEF- capsaicin patch patch 
Suzhou Vastech Medical Technology 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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Active ingredients Purpose

Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic

Uses

For temporary relief associated with:

Warnings

For external use only

Do not use:

When using this product:

Stop use and ask a doctor if:

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 Poision Control Center right away.

Directions

Adults and Children 12 years of age and over:

Clean and dry affected area.
Peel off protective film and apply patch once or twice a day.
Apply patch an hour after and before shower or bath. Patch will remain effective for 8 hours.

Children Under 12 Years of Age: Consult a physician.

Inactive ingredients

Belladonna extract, camphor, diphenhydramine, lanolin, peppermint oil, rubber, vaseline, methyl salicylate, polyster resin, zinc oxide

Distributed by:

MCURE HEALTH SOLUTIONS INC.

20819 Currier Rd #200

City of Industry, CA 91789

MADE IN CHINA

PA-200

HOT PAIN RELIEF 
capsaicin patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71183-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN1.2 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
BELLADONNA LEAF (UNII: 6GZW20TIOI)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
DIPHENHYDRAMINE (UNII: 8GTS82S83M)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
Product Characteristics
Color    Score    
ShapeRECTANGLE (13cm*18cm) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71183-002-254800 mg in 1 PATCH; Type 0: Not a Combination Product06/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/28/2017
Labeler - Suzhou Vastech Medical Technology Co., Ltd (543772485)
Registrant - Suzhou Vastech Medical Technology Co., Ltd (543772485)
Establishment
NameAddressID/FEIBusiness Operations
Suzhou Vastech Medical Technology Co., Ltd543772485manufacture(71183-002)

Revised: 6/2017
Document Id: 530e42a3-a5da-1c49-e054-00144ff88e88
Set id: 530e42a3-a5d9-1c49-e054-00144ff88e88
Version: 1
Effective Time: 20170628
 
Suzhou Vastech Medical Technology Co., Ltd