CAPSAICIN HOT PATCHES- capsaicin patch 
Cardinal Health, 110 dba LEADER

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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Leader Capsaicin Hot Patches

For External Use Only

Uses

Temporary relief of minor pain associated with:

Purpose

Temporary relief of minor pain associated with: arthritis, minor backache, muscle strains,
muschle sprains, bruises

Active Ingredients

Capsaicin: 0.025%...........................Topical Analgesic

Inactive Ingredients:

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Directions for Use:

For Use on Adults and Childrens 12 Years of Age or Older

Caution:

Keep Out of Reach of Children

if swallowed, contact a poison control center immediately.

Storage and Care:

Do Not Use:

Use Only as Directed:

Stop Use immediately and Seek Medical Attention if:

QUESTIONS

TOLL-FREE

Customer Care Help Line
866-326-1313

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017


Made in China

LABEL

Capsaicin Hot Path

CAPSAICIN HOT PATCHES 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0556
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0556-12 in 1 BOX06/01/2020
19 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2017
Labeler - Cardinal Health, 110 dba LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(70000-0556)

Revised: 1/2023
Document Id: f202f8b0-d56e-9117-e053-2a95a90a97bf
Set id: 76e6bc39-643c-4264-8d98-0e4fa7d778e2
Version: 4
Effective Time: 20230111
 
Cardinal Health, 110 dba LEADER