2-COUNT HEAT PATCHES- capsaicin patch 
QUALITY CHOICE (Chain Drug Marketing Association)

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.

----------

HEAT PATCH

For External Use Only

Uses

Temporary relief of minor pain associated with:

Purpose

Temporary relief of minor pain.

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, contacr a poison control center immediately.

Storage and Care:

Do Not Use:

Use Only as Directed:

  • Follow the below directions for use.
  • Avoid contact with eyes, mucus membrances or skin rashes.

Stop Use immediately and Seek Medical Attention if:

  • Rash, itching or excessive skin irritation develops
  • Conditions worsens
  • Symptons persist more than 7 days
  • Symptoms clear, and reoccur within a few days

QUESTIONS

Customer Care Help Line
248-449-9300
www.qualitychoice.com

LABEL

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48375

Made in China

Capsaicin Heat Path

2-COUNT HEAT PATCHES 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-308
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:63868-308-022 in 1 BOX06/01/2017
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 - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(63868-308)

Revised: 6/2017
Document Id: c9351a5f-6cc8-4b47-9aa3-5e0cab0b67a0
Set id: 722f5353-df01-4c4e-b6ce-0daa5f4a3c63
Version: 1
Effective Time: 20170614
 
QUALITY CHOICE (Chain Drug Marketing Association)